CN102349878A - Microporous release osmotic pump controlled release tablet and preparation method thereof - Google Patents
Microporous release osmotic pump controlled release tablet and preparation method thereof Download PDFInfo
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- CN102349878A CN102349878A CN201110311201XA CN201110311201A CN102349878A CN 102349878 A CN102349878 A CN 102349878A CN 201110311201X A CN201110311201X A CN 201110311201XA CN 201110311201 A CN201110311201 A CN 201110311201A CN 102349878 A CN102349878 A CN 102349878A
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Abstract
The invention relates to a microporous release osmotic pump controlled release tablet and a preparation method thereof. In the microporous release osmotic pump controlled release tablet, a certain amount of and even a small amount of macromolecular hydrophilic or water-soluble polymer as a pore-foaming agent is added to form continuous micropores to provide channels for drug release, and mechanical drilling is not needed, thereby simplifying the preparation process, greatly reducing the production cost and labor intensity and improving the stability and safety of the preparation.
Description
Technical field
The present invention relates to a kind of micropore releasing osmosis pump sheet and preparation method thereof.This micropore releasing osmosis pump sheet need not to carry out laser boring; Through adding mode that a certain amount of macromole hydrophilic polymer forms micropore as porogen is that the release of medicine provides passage; Not only simplified preparation process; Greatly reduce production cost, and improved the safety of preparation.The invention belongs to field of pharmaceutical preparations.
Background technology
Two Australian scholars of nineteen fifty-five Rose and Nelson have invented the osmotic pumps that is used for animals administer easily; Since Alza company has carried out simplify improving to osmotic pumps from the seventies in 20th century; Osmotic pump preparation has successively experienced elementary osmotic pump; The single chamber double layer osmotic pump; Two-chamber osmotic pump, for the physiological rhythm that adapts to human body has been developed forms such as discharging osmotic pumps when selecting, but above-mentioned osmotic pump preparation all need lean on mechanical punching could realize drug release.Though above-mentioned preparation all can be realized the lasting release of medicine, the operation of above-mentioned osmotic pump preparation suitability for industrialized production is too much, and each Working Procedure Controlling index request is very strict; The production difficulty is big; Production cycle is long, and cost is high, and the high deficiency of percent defective has seriously limited the popularization of osmotic pumps product.See that from the development course of osmotic pumps the industrialized development of osmotic pumps has all been quickened in the simplification of osmotic pumps structure and technology each time, therefore, research structure is simple, and the suitability for industrialized production difficulty is low, and the osmotic pumps of low production cost is the important directions of this area.
Summary of the invention
The object of the invention aims to provide a kind of micropore releasing osmosis pump sheet pharmaceutical preparation that need not to punch and preparation method thereof.Not only simplify preparation process, greatly reduced production cost, and improved the safety of preparation.
For realizing the foregoing invention purport, the present invention adopts following technical scheme:
Prepare a kind of micropore releasing osmosis pump sheet, comprise label and coating membrane, wherein label contains principal agent and penetrating agent, and coating membrane contains filmogen and porogen, it is characterized in that, porogen is macromole hydrophilic or water-soluble polymer.The porogen that this macromole hydrophilic or water-soluble polymer form can be so that form minim channel on the coating membrane of this controlled release tablet in aqueous solution; And through this passage; Small-molecule substances such as water comprise that medicine can free in and out, thereby can will discharge medicine.The present invention finds that surprisingly the duct that macromolecule polyalcohol forms forms effective protective layer around tablet, can prevent the obstruction in duct.
Further; Facts have proved; When above-mentioned porogen molecular weight greater than 2000 the time, the minim channel of formation is fit to the release of most drug, and; Molecular weight according to medicine is different; Can select the porogen of different molecular weight for use, wherein, because most compound medicine molecular weight is 10～1000; So be preferably the porogen that molecular weight is 5000-500000, and the effective site of Chinese medicine and extract or biomacromolecule desired molecule amount are in above-mentioned scope bigger numerical or higher.Through experiment showed, molecular weight in a large number at 50～500 medicine, discharge during at 5000-15000 comparatively smoothly in molecular weight the best, and molecular weight 7000-12000 is better.This perhaps is to be subjected to other adjuvants or preparation technology like the influence of processes such as granulation to drug release.But the consumption that it should be noted that porogen changes, and can influence the selection of its molecular weight, in other words, the porogen molecular weight big/hour, can suitably reduce/increase the consumption of porogen, can make the release profiles of medicine reach unanimity.Simultaneously, because the space structure of each drug molecule is different, physicochemical property is different, and above data also can change to some extent.
Wherein said porogen includes but not limited to the analog of Polyethylene Glycol or hydroxypropyl cellulose or alginic acid (sodium) or maltodextrin or poloxamer or glucosan or polyvidone or above-claimed cpd.
Macromolecule polyalcohol is adopted in more surprised discovery, can reduce the consumption of porogen greatly,, even more is low to moderate 1% o'clock to 5% when low, and the duct also can form, but during greater than 3% consumption then the duct distribute more even.
Through experiment showed, that working as above-mentioned porogen is 3%～45% of coating membrane weight, the micro channel size that formed in preferred 5%～30% o'clock is more consistent, and it is more even to distribute, and makes drug release more accurate.And for macromolecular drug, be lower than 10% and also can satisfy release request.
Above-mentioned micropore releasing osmosis pump sheet, said coating membrane is 10%～35% of a label weight, preferred 15%～25%.
Above-mentioned micropore releasing osmosis pump sheet, wherein said filmogen is selected from the mixture of one or more compositions in cellulose acetate, ethyl cellulose, hydroxypropyl emthylcellulose, the polyacrylic resin, is preferably cellulose acetate.
Above-mentioned micropore releasing osmosis pump sheet also has penetrating agent, and described penetrating agent is selected from the mixture of one or more compositions in sodium chloride, potassium chloride, mannitol, the sorbitol, is preferably sodium chloride or mannitol.Simultaneously, also can comprise permeation-promoter, permeation-promoter is selected from the mixture of one or more compositions in microcrystalline Cellulose, alginic acid, alginate, propylene glycol alginic acid ester, the Polyethylene Glycol, is preferably microcrystalline Cellulose, alginic acid or propylene glycol alginic acid ester.
Further, described micropore releasing osmosis pump sheet also can comprise plasticizer in the wherein said coating membrane.Wherein said plasticizer is selected from the mixture of one or more compositions in triethyl citrate, dibutyl sebacate, phthalic acid ester, the Macrogol 4000, is preferably dibutyl sebacate.
Above-mentioned micropore releasing osmosis pump sheet can also comprise adjuvant commonly used in the tablets such as filler, binding agent, fluidizer in the label.
And, described micropore releasing osmosis pump sheet, it also comprises the film-coat layer that contains principal agent that is positioned at outside the coating membrane.
The present invention also comprises the method for described micropore releasing osmosis pump sheet, and comprising following steps: principal agent, adjuvant that (1) will prepare label mix, granulate, and carry out tabletting, make label; (2) material that will prepare coating membrane is made into coating solution with suitable solvent, and the label that step (1) makes is put in the coating machine, carries out coating with coating solution, accounts for 10%～35% of label weight to coating membrane weight, volatilizes solvent after the taking-up, makes coated tablet.Can be found out that by above preparation technology osmotic pump controlled release tablet of the present invention can be made by the preparation technology and the equipment of conventional tablet fully, very be fit to the big production of technology, simultaneously, need not to transform production line and equipment, production cost reduces greatly.
Further, the prepared coated tablet of said method can also be put in the coating machine, carries out film-coated step with the film coating liquid that contains/do not contain principal agent.
As principal agent of the present invention, being meant pharmaceutically has finger can influence organism physiology, biochemistry and pathological process, in order to the chemical substance of prevention, diagnosis, treatment disease and family planning; The unification compound can be, also compositions, live part can be; Extract, biomacromolecule etc.And principal agent can be water soluble drug, also can embarrass water-soluble medicine.
As the specific embodiment of the invention; Principal agent is wherein selected desmethylvenlafaxine (Desvenlafaxine) or its pharmaceutical salts for use; Be preferably the succinic acid desmethylvenlafaxine, its chemistry is by name: 1-[2-(dimethylamino)-1-(4-hydroxy phenyl) ethyl] Hexalin, have another name called the O-desmethylvenlafaxine.
As one of embodiment of above-mentioned described micropore releasing osmosis pump sheet, the present invention provides a kind of succinic acid desmethylvenlafaxine micropore releasing osmosis pump sheet, by label, coating membrane be positioned at the outer film-coat that contains principal agent of coating membrane and form.
Wherein, in the described label, count by weight percentage, contain and reach succinic acid desmethylvenlafaxine 5%～50%, penetrating agent 10%～35%, permeation-promoter 20%～40%, lubricant 0.5%～1%.Can also comprise medicinal adjuvants commonly used such as filler.In the described coating membrane, count by weight percentage, contain filmogen 50%～70%, porogen 5%～45%, and coating membrane is 10%～35% of a label weight.Can also contain plasticizer 3%～10% in the coating membrane.Wherein, preferred porogen is 10%-30%.When containing principal agent in the said film-coat, count by weight percentage, contain succinic acid desmethylvenlafaxine 10%～40%, filmogen 50%～80%, plasticizer 5%～10%.
Further, above-mentioned dalfopristin or the first venlafaxine micropore releasing osmosis pump sheet of going in the described label, also includes but not limited to filler pharmaceutically commonly used, lubricant, adhesive, fluidizer, wetting agent etc.And, can be through preparing like above-mentioned method for preparing.
The present invention is surprised to find that; Micropore releasing osmosis pump sheet of the present invention; Need not punch; But it is a certain amount of through using; Or even porogen has in a small amount formed continuous duct; Thereby avoided through the existing a series of defectives of laser boring prepared controlled releasing penetrant pump, for example cost is higher, shortcoming such as the low and labor intensity of yield rate is big.
Micropore releasing osmosis pump sheet of the present invention is compared with existing osmotic pump preparation, has outstanding advantage, for example:
(1) need not to adopt once more machinery (like laser etc.) punching, cost reduces.Because manufacturing enterprise does not need the expensive laser drilling device of purchasing price, need not often to change the laser tube of rapid wear, otherwise uses common sheeting equipment and coating equipment can produce the good controlled release tablet of releasing effect, and equipment cost is reduced greatly.
(2) work simplification, labor intensity reduces, and the reliability of technology increases.Owing to reduced operations such as laser boring, artificial chip select, it is simpler relatively that technology becomes, thereby improved the reliability and stability of technology.In the production because machining process control is improper, the probability that occurs defective batch reduces greatly.
(3) safety of preparation improves.Owing to adopt the micropore mode to discharge medicine; Than adopt single laser duct safety many; The micropore mode runs into the Digestive system perforating agent after medicine gets in the body can produce the duct voluntarily, the laser instrument no marking can not occur, the degree of depth of beating, punch not enough more and the not positive problem of punching; Invalid or the prominent problem such as release that single duct stop up to be occurred by food also can not occur, thereby safety improves greatly.
(4) because the present invention adopts the porogen of macromolecule, and the micro channel of formation can make that greater than the drug molecule amount medicine freely discharges, the release amount is more accurate.
(5) reduced cost.Because preparation technology is simple, need not special installation, cost lowers greatly.Simultaneously, the porogen consumption is less, and porogen often adopts novel auxiliary material usually; Cost an arm and a leg, in long-term production, the cost of its input and equipment etc. are equally matched even higher; So after commercial production, the reduction of porogen consumption will further reduce production costs.
(6) through adjustment porogen consumption or kind, can be fit to the medicine of different molecular weight or space structure, applied widely.
Description of drawings
The drug accumulation release profiles of Fig. 1: embodiment
The specific embodiment
Below come further to explain or explanation content of the present invention through embodiment.Described embodiment only in order to help to understand content of the present invention, should not be understood that the qualification to purport of the present invention and protection domain.
Drug release determination method of the present invention is release medium referring to two appendix XD first methods of Chinese Pharmacopoeia version in 2010 with water.
Embodiment 1
Label is formed:
Coating membrane is formed:
Cellulose acetate 21g
Hydroxypropyl cellulose (Klucel LF) 9g
Dibutyl sebacate 2g
Process 1000 through being prepared as follows method:
(1) the sodium chloride pulverizing is got in the label preparation, crosses 100 mesh sieves, with medicine, microcrystalline Cellulose mix homogeneously, is wetting agent with ethanol; The system soft material is crossed 30 mesh sieves and is granulated, and dries granulate 2 hours for 50 ℃; Add magnesium stearate, mixing, tabletting adopts 1000 of conventional pressed-disc technique compactings.
(2) label coating: get cellulose acetate, add acetone 600ml, stir and make dissolving; Other gets hydroxypropyl cellulose (Klucel LF) and puts in the measuring bottle of 50ml, add water make its dissolving after, join in the above-mentioned 1500ml cellulose acetate acetone soln; The limit edged stirs; Make all dissolvings of hydroxypropyl cellulose (Klucel LF), add dibutyl sebacate and shake up, make coating solution.The above-mentioned label that makes is put in the coating machine, and logical hot blast maintains the temperature between 30-40 ℃, sprays into coating solution.Be positioned in 40 ℃ the environment and volatilize solvent, promptly get.
Adopt two appendix XD first methods of Chinese Pharmacopoeia version in 2010 to measure the release degree of said preparation, measure the result and see table 1, the cumulative release curve is seen accompanying drawing 1.
Embodiment 2
Label is formed:
Coating membrane is formed:
Ethyl cellulose 6.25g
Poloxamer 237 6.75g
Triethyl citrate 2g
Process 1000 through following method for preparing:
(1) the mannitol pulverizing is got in the label preparation; Crossing 100 mesh sieves, with succinic acid desmethylvenlafaxine, HPMC-K4M, HPMC-K100LV mix homogeneously, is wetting agent with ethanol; The system soft material; Cross 30 mesh sieves and granulate, dried granulate 2 hours for 45 ℃; Add magnesium stearate; Mixing, tabletting adopts 1000 of conventional pressed-disc technique compactings.
(2) label coating: get poloxamer 237, ethyl cellulose, hydroxypropyl cellulose, add ethanol 1500ml, stir and make dissolving.Add triethyl citrate, shake up, make coating solution.The above-mentioned label that makes is put in the coating machine, and logical hot blast maintains the temperature between 30～40 ℃, sprays into coating solution.Be positioned in 40 ℃ the environment and volatilize solvent, promptly get.
Adopt two appendix XD first methods of Chinese Pharmacopoeia version in 2000 to measure the release degree of said preparation, measure the result and see table 1, the cumulative release curve is seen accompanying drawing 1.
Embodiment 3
Label is formed:
Coating membrane is formed:
Cellulose diacetate 26.5g
Hyprolose Klucel GF 1.5g
Dibutyl sebacate 2g
The film-coat layer that contains principal agent is formed:
Succinic acid desmethylvenlafaxine 15g
Hydroxypropyl methylcellulose 20g
Polyethylene Glycol (1000) 2g
Process 1000 through following method for preparing:
(1) label preparation: sodium chloride is pulverized, added principal agent, 1/2 microcrystalline Cellulose, cross 60 mesh sieves, mix homogeneously.Add 10% polyvinylpyrrolidone k-30 alcoholic solution and process soft material in right amount, cross 30 mesh sieves and granulate, place 50 ℃ of heat dryings of baking oven.Prepared granule adds remaining microcrystalline Cellulose and magnesium stearate mixing, adds tablet machine with carrying out tabletting.
(2) label coating: it is an amount of to get acetone, adds cellulose diacetate and makes dissolving; Other gets hyprolose KlucelCF and adds water and make dissolving in right amount, slowly joins in the above-mentioned cellulose acetate acetone soln, adds dibutyl sebacate again and makes dissolving, promptly gets coating solution.
Get label, put in the coating pan, logical hot blast maintains the temperature between 30～40 ℃, sprays into coating solution and carries out coating.Be positioned in 40 ℃ the environment and volatilize solvent, promptly get coated tablet.
(3) comprise the film-coat layer of principal agent: it is an amount of to get 70% ethanol, adds hydroxypropyl methylcellulose and makes dissolving, adds succinic acid desmethylvenlafaxine and Polyethylene Glycol (2000) again and makes dissolving, promptly gets the film coating liquid that contains principal agent.
Get above-mentioned coated tablet, put in the coating pan, logical hot blast maintains the temperature between 30～35 ℃, sprays into the above-mentioned film coating liquid that contains principal agent and carries out coating.Be positioned in 40 ℃ the environment and volatilize solvent, promptly get.
According to the identical method of embodiment 3, prepare three batches of products.Adopt two appendix XD first methods of Chinese Pharmacopoeia version in 2010 to measure the release degree of said preparation, measure the result and see table 1, the cumulative release curve is seen accompanying drawing 1.
Embodiment 4
Label is formed:
Coating membrane is formed:
Cellulose diacetate 5g
Hydroxypropyl first fiber Klucel JF 3g
Dibutyl sebacate 2g
The film-coat layer that contains principal agent is formed:
Succinic acid desmethylvenlafaxine 25g
Hydroxypropyl methylcellulose 20g
Polyethylene Glycol (1000) 2g
Process 1000 through following method for preparing:
(1) label preparation: sodium chloride is pulverized, added principal agent, 1/2 microcrystalline Cellulose, cross 60 mesh sieves, mix homogeneously.Add 10% polyvinylpyrrolidone k-30 alcoholic solution and process soft material in right amount, cross 30 mesh sieves and granulate, place 50 ℃ of heat dryings of baking oven.Prepared granule adds remaining microcrystalline Cellulose and magnesium stearate mixing, adds tablet machine with carrying out tabletting.
(2) label coating: it is an amount of to get acetone, adds cellulose diacetate and makes dissolving; Other gets hyprolose Klucel JF and adds water and make dissolving in right amount, slowly joins in the above-mentioned cellulose acetate acetone soln, adds dibutyl sebacate again and makes dissolving, promptly gets coating solution.
Get label, put in the coating pan, logical hot blast maintains the temperature between 30～40 ℃, sprays into coating solution and carries out coating.Be positioned in 40 ℃ the environment and volatilize solvent, promptly get coated tablet.
(3) comprise the film-coat layer of principal agent: it is an amount of to get 70% alcohol, adds hydroxypropyl methylcellulose and makes dissolving, adds succinic acid desmethylvenlafaxine and Polyethylene Glycol (1000) again and makes dissolving, promptly gets the film coating liquid that contains principal agent.
Get above-mentioned coated tablet, put in the coating pan, logical hot blast maintains the temperature between 30～35 ℃, sprays into the above-mentioned film coating liquid that contains principal agent and carries out coating.Be positioned in 40 ℃ the environment and volatilize solvent, promptly get.
According to the identical method of embodiment 4, prepare three batches of products.Adopt two appendix XD first methods of Chinese Pharmacopoeia version in 2010 to measure the release degree of said preparation, measure the result and see table 1, the cumulative release curve is seen accompanying drawing 1.
Above-mentioned test illustrates that also the operability of micropore releasing osmosis pump blade technolgy of the present invention is good, has good repeatability.
Each embodiment desmethylvenlafaxine cumulative release degree of table 1
What need explanation is that above embodiment is just to illustrating the present invention.Under the prerequisite that does not depart from spirit of the present invention and essence, those skilled in the art can design multiple alternative of the present invention and improvement project, and it all should be understood to be within protection scope of the present invention.
Claims (10)
1. a micropore releasing osmosis pump sheet comprises label and coating membrane, and wherein label contains principal agent and penetrating agent, and coating membrane contains filmogen and porogen, it is characterized in that, porogen is macromole hydrophilic or water-soluble polymer.
2. the described micropore releasing osmosis pump of claim 1 sheet is characterized in that, said porogen molecular weight is preferably 5000-500000 greater than 2000, and is best at 7000-12000.
3. claim 1 or 2 described micropore releasing osmosis pump sheets, wherein said porogen is selected from the analog of Polyethylene Glycol or hydroxypropyl cellulose or alginic acid or maltodextrin or poloxamer or glucosan or polyvidone or above-claimed cpd.
4. the said micropore releasing osmosis pump of claim 3 sheet is characterized in that, porogen is 3%～45% of a coating membrane weight, preferred 5%～30%.
5. the said micropore releasing osmosis pump of claim 4 sheet is characterized in that coating membrane is 10%～35% of a label weight, preferred 15%～25%.
6. each described micropore releasing osmosis pump sheet of claim 1-5; Wherein said filmogen is selected from the mixture of one or more compositions in cellulose acetate, ethyl cellulose, hydroxypropyl emthylcellulose, the polyacrylic resin, is preferably cellulose acetate.
7. each described micropore releasing osmosis pump sheet of claim 1-6, wherein said penetrating agent is selected from the mixture of one or more compositions in sodium chloride, potassium chloride, mannitol, the sorbitol, is preferably sodium chloride or mannitol.
8. according to each described micropore releasing osmosis pump sheet of claim 1-7, also comprise plasticizer and/or permeation-promoter in the wherein said coating membrane.
9. each described micropore releasing osmosis pump sheet of claim 1-8, it also comprises and is positioned at the outer film-coat layer that contains or do not contain principal agent of coating membrane.
10. method for preparing for preparing the described micropore releasing osmosis pump of claim 1-9 sheet, comprising following steps: principal agent, adjuvant that (1) will prepare label mix, granulate, and carry out tabletting, make label; (2) material that will prepare coating membrane is made into coating solution with suitable solvent, and the label that step (1) makes is put in the coating machine, carries out coating with coating solution, accounts for 10%～35% of label weight to coating membrane weight, volatilizes solvent after the taking-up, makes coated tablet; And, also comprise in the above-mentioned method for preparing or do not comprise the prepared coated tablet of step (2) is put in the coating machine, carry out film-coated step with the film coating liquid that contains or do not contain principal agent.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN111346067A (en) * | 2020-03-11 | 2020-06-30 | 广东科泰鼎润药业科技有限公司 | Controlled release preparation of guanfacine and preparation method thereof |
| CN112999179A (en) * | 2019-12-20 | 2021-06-22 | 成都康弘药业集团股份有限公司 | Pharmaceutical composition containing venlafaxine hydrochloride |
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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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2011
- 2011-10-14 CN CN201110311201.XA patent/CN102349878B/en active Active
Patent Citations (2)
| 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 |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN112999179A (en) * | 2019-12-20 | 2021-06-22 | 成都康弘药业集团股份有限公司 | Pharmaceutical composition containing venlafaxine hydrochloride |
| 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 |
| CN111346067A (en) * | 2020-03-11 | 2020-06-30 | 广东科泰鼎润药业科技有限公司 | Controlled release preparation of guanfacine and preparation method thereof |
| 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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| CN102349878B (en) | 2016-05-11 |
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