CN101337074A - New use of polyvinylpyrrolidone in pharmacy - Google Patents
New use of polyvinylpyrrolidone in pharmacy Download PDFInfo
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- CN101337074A CN101337074A CNA2008100126095A CN200810012609A CN101337074A CN 101337074 A CN101337074 A CN 101337074A CN A2008100126095 A CNA2008100126095 A CN A2008100126095A CN 200810012609 A CN200810012609 A CN 200810012609A CN 101337074 A CN101337074 A CN 101337074A
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Abstract
The invention relates to the novel pharmaceutical application of PVP, which belongs to the technical field of the medicine. The PVP belongs to the water-soluble polymer, and is easily soluble in polar organic solvent, such as water and ethanol. The PVP is usually adopted as the adhesive of the oral solid preparation, the thickener in liquid oral preparation and the adhesive, the retardant and the penetration enhancer in sustained and controlled release preparation. The PVP can be taken as the porogenic agent for the formulation design of the oral osmotic pump preparation. By taking the PVP as the porogenic agent, coating membrane can be brighter than the coating membrane with PEG as the porogenic agent, and the appearance is better. The PVP has good characteristics when being adopted as the porogenic agent, thereby the PVP is a good substitute for polyethylene glycol as the porogenic agent. By adopting the PVP, the water permeation ratio of the porogenic agent can be adjusted, thereby the release rate of the medicine can be adjusted.
Description
Technical field
The present invention relates to medical technical field, relate to the new purposes of polyethylene pyrrole sieve alkane ketone (PVP) in pharmacy.
Background technology
In recent years, the superiority of macromolecular material PVP is familiar with more and more, and the application in the pharmaceutics research and development is also increasingly mature.PVP belongs to water-soluble polymer, soluble in water and ethanol isopolarity organic solvent.At present, except making the adhesive of oral solid formulation, in oral liquid,, in sustained-release preparation, do adhesive, blocker, penetrating agent etc. as thickening agent.
PVP application has in other respects also obtained further investigation.1. be a heat subject as absorption in the body of solid dispersion carrier raising insoluble drug always, reach this purpose, must consider to improve its dissolubility and dissolution velocity, the solid dispersion physical ability is dispersed in insoluble drug in a kind of water-soluble material with molecule, colloidal state, crystallite or unformed shape, can significantly improve dissolution rate and improves absorption.PVP can be used as the carrier of preparation solid dispersion.2. the PVP that makes the thin film coating material regular size is more satisfactory because of its pliability, can be used as medicinal filmogen or share with other film materials.Practice proves that also it is in the good application future of the tool in this field.Studies have shown that, PVP can be used for the film coating procedure of water and two kinds of systems of organic solvent, and the advantage of its coating has: can improve the adhesive capacity of film to the surface, improve the dispersibility of color lake or dyestuff, can be used as film plasticizer, can change with the hydrophobic material is the disintegration time of the thin film of base material.Typical concentrations during coating is 0.5%-5%.3. forming sterilization complex PVP-I (Acu-Dyne) with iodine is a kind of soluble complex that iodine and PVP form, and is a kind of efficient, spectrum new type bactericide.Compare with iodine, PVP-I has that volatility is little, good water solubility, advantage such as nonirritant, anaphylaxis almost.4. be used for preparing medicament nano granule PVP and also can be used on the newtype drug delivery system.In addition, in the exploitation of injection, injection PVP can be used as solubilizing agent (in some kinds, the dissolubility of medicine is obviously improved by PVP), and it uses also more and more as crystallizing inhibitor.
The release of Oros drug-supplying system is steady, blood concentration fluctuation is little, and the influence that release unable to take food thing and gastrointestinal tract pH change helps improving compliance of patients, and the inside and outside dependency is good.In the past few decades, the oral osmotic pumping system has obtained significant progress.Nineteen seventies, Theeuwes has at first developed basic osmotic pumps, and (mono-layer osmotic pump, elementary osmoticpump EOP), and have founded relevant theory.Mono-layer osmotic pump has its limitation, only is applicable to soluble drug, so the new method of many raising insoluble drug dissolubility is applied to the osmotic pumps technology successively, as reconcile pH value, with cyclodextrin inclusion compound etc.Certainly, for insoluble drug, preferably discharge medicine with suspension.So just have human macromolecule suspending to make monolayer polymolecularity osmotic pumps, develop at last and the ideal controlled-release medicament delivery system of a kind of insoluble drug---and double layer osmotic pump (also claim plug-type osmotic pumps, push-pull osmotic pump, PPOP).(polyethylene oxide PEO) is used for the medicine layer as the suspendible material to Gan Yong etc., as the boosting layer, has realized good controlled-release function with high molecular PEO with low-molecular-weight polyoxyethylene.The details of relevant osmotic pumps please refer to relevant summary.
Through many-sided test, confirmed that PVP can be used as the prescription design that porogen is used for the Oros preparation.
Summary of the invention
The object of the present invention is to provide PVP in pharmacy new purposes and PVP as the application of porogen in osmotic pump preparation preparation.
Osmotic pump type controlled release preparation is as the typical case of sustained-release preparation representative, be with osmotic pressure as release power, be a kind of preparation technique of feature with the zero level release dynamics.Porogen means and add water-soluble substances in coating membrane, dissolves when preparation is met water, regulates the water penetration of film, regulates the drug release of this preparation of infiltration.Porogen commonly used mainly contains Polyethylene Glycol (PEG), sorbitol etc., and the pharmaceutical grade adjuvant seldom.Soluble in water and the ethanol isopolarity organic solvent of PVP, the PVP strand is more a lot of than length such as PEG, and easy and filmogen strand interacts, and is that coating solution has better film property; Find also in experiment that when vast scale uses porogen (for example porogen-cellulose acetate ratio is 1: 1) than the coating membrane light as porogen such as PEG, outward appearance is better as the coating membrane of porogen for PVP.PVP possesses the superperformance of doing porogen, and the present invention replaces these Polyethylene Glycol etc. as porogen with PVP.PVP is 5～25% of a coating solution solid content as the conventional amount used of porogen.PVP model commonly used is PVP K29/32, PVP K90, PVP K120.
The adding of PVP can be regulated the penetrating rate of water of coating membrane, thereby regulates release rate of drugs.
Description of drawings
Fig. 1 is dipyridamole double-layer osmotic pump tablet (PVP makes a porogen) release profiles
Fig. 2 is dipyridamole floating osmotic-pump (PVP makes a porogen) release profiles
The specific embodiment
Embodiment 1
Dipyridamole double-layer osmotic pump tablet (PVP makes porogen):
Sheet heart prescription:
Medicated layer dipyridamole 100g
Polyoxyethylene (molecular weight 300,000) 250g
Sodium chloride 50g
Magnesium stearate is an amount of
Boosting strata oxygen ethylene (molecular weight 7,000,000) 160g
Sodium chloride 40g
Magnesium stearate is an amount of
1000
Coating solution
CA 30g
PVP?K?30 6g
Acetone 1000ml
Ethanol 100ml
Supplementary materials such as dipyridamole, polyoxyethylene (molecular weight 300,000,7,000,000), polyethylene pyrrole sieve alkane ketone (PVPK30), xylitol, magnesium stearate are pulverized until crossing 80 mesh sieves.Take by weighing dipyridamole 100g, polyoxyethylene (molecular weight 300,000) 250g, and with its mix homogeneously, dry granulation is crossed 18 mesh sieve granulate, take by weighing weight for doing particulate 1% magnesium stearate, with dried granule mixing, to play lubricated fluidizer effect, this is the medicated layer granule; Take by weighing polyoxyethylene (molecular weight 7,000,000) 160g, sodium chloride 40g, and with its mix homogeneously, take by weighing weight and be 0.5% magnesium stearate of mixed-powder, mixing, to play lubricated fluidizer effect, this is the boosting layer; Next charge and attack sheet with No. 12 scrobiculas, the heavily about 600mg of sheet is called the sheet heart.
Take by weighing cellulose acetate 30g and be dissolved in the 1000ml acetone, measure ethanol 100ml, take by weighing PVPK30 6g and be dissolved in about 60ml ethanol, add in the cellulose acetate acetone soln, the PVP that will stick on the beaker with remaining ethanol washes in the cellulose acetate acetone soln.When each material mix homogeneously promptly gets coating solution.
Next, be the process of coating.The sheet heart is put in the coating pan 35 rev/mins of coating pan rotating speeds, 40 ℃ of sheet bed tempertaures, coating solution flow velocity 7ml/min.When being about 7%, the coating weightening finish stops coating.Coated tablet was dried 12 hours down at 40 ℃ then.
After the coated tablet oven dry, the hole of stamping 1.0mm with the method for machinery or laser at the medicated layer coating membrane.Its release profiles as shown in Figure 1.
Dipyridamole floating osmotic-pump (PVP makes porogen):
Sheet heart prescription:
Dipyridamole 50g
Polyoxyethylene (molecular weight 7,000,000) 30g
Sodium chloride 50g
Glucose 70g
Magnesium stearate is an amount of
1000
Coating solution
CA 30g
PVP?K?30 30g
Acetone 1000ml
Ethanol 400ml
Supplementary materials such as dipyridamole, polyoxyethylene (molecular weight 7,000,000), sodium chloride, glucose, magnesium stearate are pulverized until crossing 80 mesh sieves.Take by weighing dipyridamole 50g, polyoxyethylene (molecular weight 7,000,000) 30g, sodium chloride 50g, glucose 70g; and with its mix homogeneously; dry granulation; cross 18 mesh sieve granulate, take by weighing weight for doing particulate 1% magnesium stearate, with dried granule mixing; to play lubricated fluidizer effect; next charge and attack sheet with No. 7 scrobiculas, the heavily about 200mg of sheet is called the sheet heart.
Taking by weighing cellulose acetate 30g is dissolved in the 1000ml acetone, measure ethanol 400ml, take by weighing PVPK30 30g and be dissolved in about 300ml ethanol, add in the cellulose acetate acetone soln, the PVP that will stick on the beaker with remaining ethanol washes in the cellulose acetate acetone soln.When each material mix homogeneously promptly gets coating solution.
Next, be the process of coating.The sheet heart is put in the coating pan 35 rev/mins of coating pan rotating speeds, 40 ℃ of sheet bed tempertaures, coating solution flow velocity 7ml/min.When being about 8%, the coating weightening finish stops coating.Coated tablet was dried 12 hours down at 40 ℃ then.
After the coated tablet oven dry, the hole of stamping 0.7mm with the method for machinery or laser on the two sides of sheet respectively.
With the opening part of sheet plug No. 0 enteric coated capsule medicated cap with holes, promptly make the two chambers of dipyridamole monolayer gas bag floationg osmotic pumps at last to the top.Its release profiles as shown in Figure 2.The preparation floating state keeps more than 12 hours.
Embodiment 3
VENLAFAXINE HCL micropore permeation pump (PVP makes porogen):
Sheet heart prescription
VENLAFAXINE HCL 37.5g
Microcrystalline Cellulose 55g
The 5%PVPK alcoholic solution is an amount of
M.S. an amount of
1000
Coating solution
CA 30g
PVP?K90 15g
Acetone 1000ml
Ethanol 200ml
Supplementary materials such as VENLAFAXINE HCL, microcrystalline Cellulose, magnesium stearate are pulverized until crossing 80 mesh sieves.Take by weighing VENLAFAXINE HCL 37.5g, microcrystalline Cellulose 55g, and with its mix homogeneously, be binding agent system soft material with the 5%PVP alcoholic solution, cross 18 mesh sieves and granulate, 40 ℃ were dried by the fire 30 minutes down, crossed 20 mesh sieve granulate, and 40 ℃ of oven dry became dried granule in 5 hours.Take by weighing weight for doing particulate 0.5% magnesium stearate, with dried granule mixing,, next charge and attack sheet, the heavily about 100mg of sheet with No. 6 scrobiculas to play lubricated fluidizer effect.
Take by weighing cellulose acetate 30g and be dissolved in the 1000ml acetone, measure ethanol 200ml, take by weighing PVP15g and be dissolved in about 150ml ethanol, add in the cellulose acetate acetone soln, the PVP that will stick on the beaker with remaining ethanol washes in the cellulose acetate acetone soln.When each material mix homogeneously promptly gets coating solution.
Next, be the process of coating.The sheet heart is put in the coating pan 35 rev/mins of coating pan rotating speeds, 40 ℃ of sheet bed tempertaures, coating solution flow velocity 7ml/min.When being about 10%, the coating weightening finish stops coating.Coated tablet was dried 12 hours down at 40 ℃ then.
After the coated tablet oven dry, the hole of stamping 0.6mm with the method for machinery or laser at coating membrane.
Claims (3)
1, the new purposes of polyethylene pyrrole sieve alkane ketone in pharmacy, it is characterized in that: it can be used as the porogen in the osmotic pump preparation.
2, according to the new purposes of the described polyethylene pyrrole of claim 1 sieve alkane ketone in pharmacy, it is characterized in that: described polyethylene pyrrole sieve alkane ketone model is: PVP K29/32, PVP K90, PVP K120.
3, the new purposes of polyethylene pyrrole sieve alkane ketone according to claim 1 in pharmacy, it is characterized in that: the consumption of described polyethylene pyrrole sieve alkane ketone is: 5～25% of coating solution solid content.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CNA2008100126095A CN101337074A (en) | 2008-08-05 | 2008-08-05 | New use of polyvinylpyrrolidone in pharmacy |
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|---|---|---|---|
| CNA2008100126095A CN101337074A (en) | 2008-08-05 | 2008-08-05 | New use of polyvinylpyrrolidone in pharmacy |
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| WO2011032386A1 (en) * | 2009-09-15 | 2011-03-24 | 北京天衡药物研究院 | Osmotic pump controlled release tablet and preparation method thereof |
| CN102151252A (en) * | 2010-02-11 | 2011-08-17 | 北京天衡药物研究院南阳天衡制药厂 | Glipizide osmotic pump type controlled release tablet |
| CN102274542A (en) * | 2011-08-30 | 2011-12-14 | 夏敬民 | Film-forming type waterproof breathable wound protecting liquid and preparation method thereof |
| CN102670549A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Ropinirole hydrochloride osmotic pump type controlled release tablet |
| CN102670553A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Venlafaxine hydrochloride osmotic pump controlled release tablet |
| CN102670559A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院南阳天衡制药厂 | Salbutamol sulfate osmotic pump type controlled release tablet |
| CN102670546A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Tamsulosin hydrochloride osmotic pump controlled-release tablet |
| CN102670539A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Metoprolol succinate osmotic pump controlled release tablet |
| CN102670542A (en) * | 2011-03-17 | 2012-09-19 | 北京天衡药物研究院 | Tramadol hydrochloride osmotic pump controlled release tablet |
| CN102670543A (en) * | 2011-03-17 | 2012-09-19 | 北京天衡药物研究院 | Osmotic pump isosorbide mononitrate quick-controlled release tablet |
| CN102670554A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Pseudoephedrine hydrochloride osmotic pump controlled release tablet |
| CN102670556A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Tacrolimus osmotic pump type controlled release tablet |
| CN102670547A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Tolterodine tartrate osmotic pump controlled release tablet |
| CN102670540A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院南阳天衡制药厂 | Verapamil hydrochloride osmotic pump type controlled release tablet |
| CN102670555A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Metoprolol fumarate osmotic pump controlled release tablet |
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| CN102670557A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Lovastatin osmotic pump controlled release tablet |
| CN102670560A (en) * | 2011-03-17 | 2012-09-19 | 北京天衡药物研究院 | Losartan potassium osmotic pump controlled release tablet |
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| CN102670548A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Paroxetine hydrochloride osmotic pump type enteric controlled release tablet |
| CN104127401A (en) * | 2013-08-28 | 2014-11-05 | 山东绿叶制药有限公司 | Osmotic pump control-released composition containing desmethylvenlafaxine benzoate compound |
| CN105030721A (en) * | 2015-08-30 | 2015-11-11 | 董贵雨 | Oral solid composite containing pramipexole dihydrochloride |
-
2008
- 2008-08-05 CN CNA2008100126095A patent/CN101337074A/en active Pending
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| CN102018682A (en) * | 2009-09-15 | 2011-04-20 | 北京天衡药物研究院 | Osmotic pump controlled-release tablet and preparation method thereof |
| US9005661B2 (en) | 2009-09-15 | 2015-04-14 | Beijing Team Hospital Management Co., Ltd. | Osmotic pump controlled release tablet and preparation method thereof |
| CN102151252A (en) * | 2010-02-11 | 2011-08-17 | 北京天衡药物研究院南阳天衡制药厂 | Glipizide osmotic pump type controlled release tablet |
| CN102151252B (en) * | 2010-02-11 | 2014-06-11 | 北京天衡药物研究院南阳天衡制药厂 | Glipizide osmotic pump type controlled release tablet |
| CN102670556A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Tacrolimus osmotic pump type controlled release tablet |
| CN102670538A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Isosorbide mononitrate osmotic pump controlled release tablets |
| CN102670546A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Tamsulosin hydrochloride osmotic pump controlled-release tablet |
| CN102670539A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Metoprolol succinate osmotic pump controlled release tablet |
| CN102670540B (en) * | 2011-03-14 | 2016-03-09 | 北京天衡药物研究院南阳天衡制药厂 | Verapamil hydrochloride osmotic pump type controlled release tablets |
| CN102670549A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Ropinirole hydrochloride osmotic pump type controlled release tablet |
| CN102670554A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Pseudoephedrine hydrochloride osmotic pump controlled release tablet |
| CN102670553A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Venlafaxine hydrochloride osmotic pump controlled release tablet |
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| CN102670557A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Lovastatin osmotic pump controlled release tablet |
| CN102670548A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Paroxetine hydrochloride osmotic pump type enteric controlled release tablet |
| CN102670550A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Pramipexole dihydrochloride osmotic pump type controlled release tablets |
| CN102670552A (en) * | 2011-03-14 | 2012-09-19 | 北京天衡药物研究院 | Vincamine osmotic pump type controlled release tablets |
| CN102670560A (en) * | 2011-03-17 | 2012-09-19 | 北京天衡药物研究院 | Losartan potassium osmotic pump controlled release tablet |
| CN102670543A (en) * | 2011-03-17 | 2012-09-19 | 北京天衡药物研究院 | Osmotic pump isosorbide mononitrate quick-controlled release tablet |
| CN102670542A (en) * | 2011-03-17 | 2012-09-19 | 北京天衡药物研究院 | Tramadol hydrochloride osmotic pump controlled release tablet |
| CN102274542A (en) * | 2011-08-30 | 2011-12-14 | 夏敬民 | Film-forming type waterproof breathable wound protecting liquid and preparation method thereof |
| CN104127401A (en) * | 2013-08-28 | 2014-11-05 | 山东绿叶制药有限公司 | Osmotic pump control-released composition containing desmethylvenlafaxine benzoate compound |
| CN105030721A (en) * | 2015-08-30 | 2015-11-11 | 董贵雨 | Oral solid composite containing pramipexole dihydrochloride |
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Application publication date: 20090107 |