CN101496793A - Sustained-release matrix tablets and preparation method thereof - Google Patents
Sustained-release matrix tablets and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a slow-release matrix tablet and a method for preparing the same. The slow-release matrix tablet is prepared by the following steps that: 1, according to the weight percentage, 20 to 80 percent of drug, 20 to 80 percent of konjac glucomannan passing a 100-mesh screen, 0 to 60 percent of xanthan gum or carrageenin, and 0 to 30 percent of diluent are weighed up and mixed to obtain a mixture 1; and 2, a binder, of which the weight accounting for that of the mixture 1 is between 10 and 40 percent, is added to the mixture 1, granulated by the wet method, dried to constant weight, and straightening-granulated by passing a 20-mesh screen; and the mixture is mixed with a lubricant, of which the weight accounting for that of the particle after straightening-granulation is between 1 and 4 percent, and pressed into the slow-release matrix tablet. The slow-release matrix tablet has the advantages that: the slow-release effect of the drug is good; the ratios of KGM and other polysaccharides are changed, and the drug-releasing process of the tablet can be conveniently controlled by using different binders; the drug-carrying system is wide; and the natural polysaccharides are wide in source and low in price.
Description
Technical field
The invention belongs to pharmaceutical preparation adjuvant field, relate to a kind of sustained-release matrix tablets and preparation method.
Background technology
Any crude drug will offer clinical use, must make the pharmaceutical preparation of various different dosage forms, and the preparation of preparation is except that crude drug, also must add the various adjuvants that some help difference in functionality such as preparations shaping, stable, solubilising, hydrotropy, slow release, controlled release and effect, the various requirement that these are used to make or allocate pharmaceutical preparation are called the pharmaceutical preparation adjuvant.Along with the development of society and the demand of new medicinal preparation, the exploitation of new type medicinal stuff has caused extensive concern.
Medicinal high polymer adjuvant can be divided into natural polymer adjuvant and semi-synthetic high polymer adjuvant again.Natural pharmaceutical polymers is meant that Gong pharmaceutical preparation that nature exists makes the macromolecular compound of adjuvant, comprises starch, cellulose, arabic gum and albumin etc.Wherein natural pharmaceutical polymers has excellent biological compatibility and inexpensive, advantage such as be easy to get, and makes it be widely used in medicine and biological technical field.
The hydrophilic gel matrix tablet as framework material, as hydroxypropyl methylcellulose etc., is the main type of present oral sustained-release preparation with the hydrophilic macromolecule material.Such tablet manufacturing technology is simple, and the equipment of general tablet manufacturing can meet the demands, and the composition by regulating skeleton etc. can obtain to have the tablet of desirable drug release feature more conveniently.Characteristics such as the consumption of framework material, hydration rate, viscosity and granularity are the key factors that influences drug release rate.
(Konjac Glucomannan KGM) is multifrequency natures such as the deposit polysaccharide that the Rhizoma amorphophalli plant tuber is rich in the Araeceae, possess hydrophilic property, thickening property, stability to Rhizoma amorphophalli glucomannan.Modern medicine study shows that Rhizoma amorphophalli glucomannan and oligosaccharide thereof have prevention and effects such as treatment diabetes and cardiovascular disease to human body.Because it has the good characteristics such as instantaneous gelation of excellent biological compatibility, gentleness, Rhizoma amorphophalli glucomannan has bigger application potential aspect medicine and pharmacology.At present both at home and abroad mainly with Rhizoma amorphophalli glucomannan and oligosaccharide thereof as food primary raw materials or health promoting product, with Rhizoma amorphophalli glucomannan also less as pharmaceutical adjunct.
Rhizoma amorphophalli glucomannan has the advantage that a lot of synthetic materials can not be compared as excipient substance slow, controlled release preparation, but Rhizoma amorphophalli glucomannan dissolubility in water is good, the swelling multiple is big, in order further to improve himself intensity and water-resistance, can adopt xanthan gum (XG) or carrageenan that Rhizoma amorphophalli glucomannan is carried out modification.After Rhizoma amorphophalli glucomannan and xanthan gum or the carrageenan blend, can produce intensive synergism between the two, and then form the very big gel of intensity, can improve the intensity and the Release Performance of matrix tablet thus.
Summary of the invention
The objective of the invention is to overcome deficiency of the prior art, a kind of sustained-release matrix tablets that improves controlled drug release and drug effect power is provided.
Second purpose of the present invention is to provide a kind of preparation method of sustained-release matrix tablets.
A kind of sustained-release matrix tablets, make by following step:
(1) percentage composition takes by weighing 20%-80% medicine, 20%-80% and crosses 100 purpose Rhizoma amorphophalli glucomannans, 0-60% xanthan gum or carrageenan by weight, and 0-30% mixing diluents obtains mixture 1;
(2) binding agent that will account for mixture 1 weight 10%-40% adds wet granulation in the mixture 1, is dried to constant weight, crosses 20 mesh sieve granulate; With the mix lubricant that accounts for particle weight 1%-4% behind the granulate, be pressed into sustained-release matrix tablets again.
Described diluent is lactose, starch, Icing Sugar, amylum pregelatinisatum, inorganic salt, mannitol or sorbitol.
Described binding agent is a water, concentration expressed in percentage by volume is the ethanol water of 5%-30%, mass percentage concentration is the starch slurry of 1%-15%, mass percentage concentration is the cellulose derivative aqueous solution of 1%-15%, mass percentage concentration is the polyvidone aqueous solution of 1%-15%, mass percentage concentration is the aqueous gelatin solution of 1%-15%, mass percentage concentration is the Polyethylene Glycol aqueous solution of 1%-15%, mass percentage concentration is the aqueous sucrose solution of 50%-70% or the Na-alginate aqueous solution that mass percentage concentration is 1%-10%.
Described cellulose derivative is methylcellulose, hyprolose, hypromellose or sodium carboxymethyl cellulose.
Described lubricant is that magnesium stearate, differential silica gel, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol and magnesium laurylsulfate are at least a.
A kind of preparation method of sustained-release matrix tablets, form by following step:
(1) percentage composition takes by weighing 20%-80% medicine, 20%-80% and crosses 100 purpose Rhizoma amorphophalli glucomannans, 0-60% xanthan gum or carrageenan by weight, and 0-30% mixing diluents obtains mixture 1;
(2) binding agent that will account for mixture 1 weight 10-40% adds wet granulation in the mixture 1, is dried to constant weight, crosses 20 mesh sieve granulate; With the mix lubricant that accounts for particle weight 1%-4% behind the granulate, be pressed into sustained-release matrix tablets again.
Described diluent is lactose, starch, Icing Sugar, amylum pregelatinisatum, inorganic salt, mannitol or sorbitol.
Described binding agent is a water, concentration expressed in percentage by volume is the ethanol water of 5%-30%, mass percentage concentration is the starch slurry of 1%-15%, mass percentage concentration is the cellulose derivative aqueous solution of 1%-15%, mass percentage concentration is the polyvidone aqueous solution of 1%-15%, mass percentage concentration is the aqueous gelatin solution of 1%-15%, mass percentage concentration is the Polyethylene Glycol aqueous solution of 1%-15%, mass percentage concentration is the aqueous sucrose solution of 50%-70% or the Na-alginate aqueous solution that mass percentage concentration is 1%-10%.
Described cellulose derivative is methylcellulose, hyprolose, hypromellose or sodium carboxymethyl cellulose.
Described lubricant is that magnesium stearate, differential silica gel, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol and magnesium laurylsulfate are at least a.
The invention has the advantages that, prepare adjuvant hydroxypropyl methylcellulose (HPMC) with existing matrix tablet commonly used and compare, slow controlled release matrix tablet of the present invention, the slow release effect of medicine is better; Change the ratio of KGM and other polysaccharide and use different binding agents can regulate and control the drug release process of tablet easily; Medicine-carried system is extensive; As natural polysaccharide wide material sources, low price; The matrix tablet preparation process is consistent with the use of conventional adjuvant, can be directly used in commercial production.
Description of drawings
Fig. 1 is that KGM (viscosity is 20000mPa.s) content is 15%, 20% and 25% o'clock, the drug accumulation release rate curve of metronidazole matrix tablet.Among the figure: when ■ is KGM content 15%, the cumulative release rate curve of metronidazole; ● during for KGM content 20%, the cumulative release rate curve of metronidazole; ▲ when being KGM content 25%, the cumulative release rate curve of metronidazole.
Fig. 2 is for being binding agent metronidazole matrix tablet release curve with water, 2%HPMC aqueous solution and 2% starch slurry.Among the figure: when ■ is binding agent with water, the cumulative release rate curve of metronidazole; ● when being binding agent with the 2%HPMC aqueous solution, the cumulative release rate curve of metronidazole; When ▲ 2% starch slurry is binding agent, the cumulative release rate curve of metronidazole.
Fig. 3 is to be the release curve of adjuvant metronidazole matrix tablet with KGM and HPMC respectively.Among the figure: ■ is a controlled slowly releasing adjuncts when being KGM, the cumulative release rate curve of metronidazole; ● when being HPMC for controlled slowly releasing adjuncts, the cumulative release rate curve of metronidazole;
Fig. 4 is the asynchronous drug release curve of KGM and XG mixed proportion.3 hours subsequently in the simulation intestinal fluid of pH=7.4, later in the simulation colonic fluid of pH=6.8 in the simulated gastric fluid of pH=1 in wherein preceding 2 hours.Among the figure: when ■ is KGM:XG=3:7, the cumulative release rate curve of cimetidine; ● during for KGM:XG=5:5, the cumulative release rate curve of cimetidine; ▲ when being KGM:XG=7:3, the cumulative release rate curve of cimetidine.
Fig. 5 is for being binding agent cimetidine matrix tablet release curve with water and 5% starch slurry.3 hours subsequently in the simulation intestinal fluid of pH=7.4, later in the simulation colonic fluid of pH=6.8 in the simulated gastric fluid of pH=1 in wherein preceding 2 hours.Among the figure: when the ■ binding agent is water, the cumulative release rate curve of cimetidine; ● when binding agent is 5% starch slurry, the cumulative release rate curve of cimetidine.
Fig. 6 is to be the release curve of adjuvant cimetidine sustained-release matrix tablets with blend polysaccharide and HPMC respectively.Among the figure: when ■ is adjuvant for the blend polysaccharide, the cumulative release rate curve of cimetidine; ● when being adjuvant for HPMC, the cumulative release rate curve of cimetidine;
The specific embodiment
Embodiment 1
A kind of sustained-release matrix tablets is made by following step
Prepare three parts of matrix tablets that KGM content is different, every part of preparation process comprises that percentage composition by weight takes by weighing 50% metronidazole, crosses 100 purpose adjuvant KGM and be respectively 15%, 20% and 25%, crosses 100 purpose lactose and is respectively 35%, 30% and obtains three parts of mixture 1 that KGM content is different with 25% lactose mixing; The water that accounts for mixture 1 weight 30% is added wet granulation in the mixture 1, is dried to constant weight, cross 20 mesh sieve granulate; With the Pulvis Talci that accounts for particle weight 1% behind the granulate, 3% magnesium stearate is mixed, and is pressed into sustained-release matrix tablets again.Place the circular matrix tablet of the heavily about 1.0g of single punch tablet machine tablet forming at last, hardness 3-6kg/cm
2Mensuration also compares the release of matrix tablet in simulated gastric fluid.Having provided KGM (viscosity is 20000mPa.s) content as Fig. 1 is 15%, 20% and 25% o'clock, the cumulative release rate curve of metronidazole.As seen from Figure 1, the increase rate of releasing drug along with KGM content reduces.KGM content is that the metronidazole matrix tablet more than 15% can form good gel layer, the phenomenon of matrix tablet disintegrate can not take place, and this may be because KGM has stronger water absorbing capacity, and hydration rate is very fast, formation gel layer that can be very fast, the diffusion of blocking medicine.
Percentage composition takes by weighing 50% metronidazole, 25% and crosses the lactose of 100 purpose KGM and 25% and mix and obtain mixture 1 by weight; Prepare three parts of mixture 1, in first part of mixture 1, add the water that accounts for mixture 1 weight 30%, add the mass percentage concentration that accounts for mixture 1 weight 30% in second part of mixture 1 and be 2% HPMC aqueous solution, add the mass percentage concentration that accounts for mixture 1 weight 30% in the 3rd part of mixture 1 and be 2% starch slurry aqueous solution, respectively wet granulation; Put into 60 ℃ of baking ovens and be dried to constant weight, cross 20 mesh sieve granulate; Add the Pulvis Talci account for particle weight 1% behind the granulate more respectively, 3% magnesium stearate is mixed, and is pressed into sustained-release matrix tablets; Place the circular matrix tablet of the heavily about 1.0g of single punch tablet machine tablet forming at last, hardness 3-6kg/cm
2Mensuration also compares the release of matrix tablet in simulated gastric fluid.Having provided with water, 2%HPMC aqueous solution and 2% starch slurry as Fig. 2 is that binding agent is as the influence of binding agent to the release of metronidazole sustained-release matrix tablet.As seen from Figure 2, be that the matrix tablet of binding agent discharges will be faster than being the matrix tablet of binding agent with 2%HPMC solution and starch slurry with water.This may be because the bond properties of 2%HPMC aqueous solution and starch slurry is better than the bond properties of water, and is stronger to the retardation of medicine.
Embodiment 3
Percentage composition takes by weighing 50% metronidazole, 25% and crosses the lactose mixing of 100 order KGM (viscosity is 20000mPas) and 25% and obtain mixture 1 by weight; The water that accounts for mixture 1 weight 30% is added wet granulation in the mixture 1, is dried to constant weight, cross 20 mesh sieve granulate; With the Pulvis Talci that accounts for particle weight 1% behind the granulate, 3% magnesium stearate is mixed, and is pressed into sustained-release matrix tablets again.Place the circular matrix tablet of the heavily about 1.0g of single punch tablet machine tablet forming at last, hardness 3-6kg/cm
2Measure the release of matrix tablet in the simulation gastro-intestinal Fluid.Having provided as Fig. 3 is the release release profiles of adjuvant cimetidine sustained-release matrix tablets (all the other preparation conditions are identical) with KGM with HPMC (viscosity is 20000mPas) respectively.As seen from Figure 3, be to discharge that to be considerably slower than with HPMC be the Metronidazole Tablet of adjuvant at Metronidazole Tablet initial stage of adjuvant with KGM.KGM is the natural biological polysaccharide, has a large amount of hydroxyls in the molecule, and they can also can form hydrogen bond with other molecules at intramolecularly or intermolecular formation association hydrogen bond, and the x-ray diffraction pattern of KGM shows that KGM mainly presents impalpable structure, and the minority crystallization is only arranged.And for HPMC, because it is cellulosic etherification derivative, crystalline texture is more.In general, the hydroxyl of crystal region has all formed hydrogen bond, and in the amorphous region, the free hydroxyl group that does not form hydrogen bond is on a small quantity then arranged, so hydrone can enter the amorphous region, with the free hydroxyl group formation hydrogen bond on the strand, promptly between strand, form the water bridge, expanded effect takes place.Therefore, KGM can form the release that hydrogel stops medicine soon, is better than HPMC at release initial stage slow release effect.
Prepare three parts of different matrix tablets of blend polysaccharide ratio, every part of preparation process comprises that percentage composition by weight takes by weighing 50% cimetidine, 25% and crosses the lactose mixing of 100 purpose blend polysaccharide (the KGM:XG ratio is respectively 3:7,5:5 and 7:3) and 25% and obtain mixture 1; The water that accounts for mixture 1 weight 30% is added wet granulation in the mixture 1, is dried to constant weight, cross 20 mesh sieve granulate; With the Pulvis Talci that accounts for particle weight 1% behind the granulate, 3% magnesium stearate is mixed, and is pressed into sustained-release matrix tablets again.Place the circular matrix tablet of the heavily about 1.0g of single punch tablet machine tablet forming at last, hardness 3-6kg/cm
2Mensuration also compares the release of matrix tablet in the simulation gastro-intestinal Fluid.KGM is different with the XG mixed proportion, and Fig. 4 is seen in the influence to drug release.As seen from Figure 4, discharge 2 hours in the pH=1 simulated gastric fluid, KGM:XG=7:3 system drug accumulation release rate is minimum.Through 3 hours release of pH=7.4 simulation intestinal fluid, the cumulative release rate of KGM:XG=3:7 system medicine is minimum.After this through the release of pH=6.8 simulation colonic fluid, it is minimum from KGM:XG=3:7 system cumulative release rate to have kept medicine.From the cumulative release rate of simulated gastric fluid and simulation stomach-intestinal liquid as seen, enter the simulation intestinal fluid after, the system that XG content is high, drug release rate is relatively low.Above experimental result shows, under acid condition, and KGM content height, blended gel is stronger to the retardation of medicine.And in neutral and subalkaline medium, XG content is higher, and blended gel is stronger to the slow releasing function of medicine.
Embodiment 5
Percentage composition takes by weighing 50% cimetidine, 25% lactose of crossing 100 order blend polysaccharide (KGM is 3:7 with the XG mixed proportion) and 25% and mixes and obtain mixture 1 by weight; Prepare two parts of mixture 1, in first part of mixture 1, add the water account for mixture 1 weight 30%, add the mass percentage concentration that accounts for mixture 1 weight 30% in second part of mixture 1 and be 5% starch slurry aqueous solution, respectively wet granulation; Put into 60 ℃ of baking ovens and be dried to constant weight, cross 20 mesh sieve granulate; Add the Pulvis Talci account for particle weight 1% behind the granulate more respectively, 3% magnesium stearate is mixed, and is pressed into sustained-release matrix tablets; Place the circular matrix tablet of the heavily about 1.0g of single punch tablet machine tablet forming at last, hardness 3-6kg/cm
2Mensuration also compares the release of matrix tablet in the simulation gastro-intestinal Fluid.Provided the drug release curve of cimetidine in the matrix tablet that water, 5% starch slurry makes as the method for binding agent as Fig. 5.As seen from Figure 6 simulated gastric fluid 2 hours, in the simulation intestinal fluid 2 hours, use water as binding agent or starch slurry and make binding agent the release of cimetidine is had no significant effect.But after discharging 4 hours, use starch slurry to make the system of binding agent, rate of releasing drug is very fast relatively, and this may be because the use of starch slurry has weakened the interaction between KGM and XG, makes drug release very fast.
Percentage composition takes by weighing 50% cimetidine, 25% lactose of crossing 100 order blend polysaccharide (KGM is 3:7 with the XG mixed proportion) and 25% and mixes and obtain mixture 1 by weight; The water that accounts for mixture 1 weight 30% is added wet granulation in the mixture 1, is dried to constant weight, cross 20 mesh sieve granulate; With the Pulvis Talci that accounts for particle weight 1% behind the granulate, 3% magnesium stearate is mixed, and is pressed into sustained-release matrix tablets again.Place the circular matrix tablet of the heavily about 1.0g of single punch tablet machine tablet forming at last, hardness 3-6kg/cm
2Measure the release of matrix tablet in the simulation gastro-intestinal Fluid.Having provided as Fig. 6 is the release release profiles of adjuvant cimetidine sustained-release matrix tablets (all the other preparation conditions are identical) with the blend polysaccharide with HPMC (viscosity is 20000mPas) respectively.As seen from Figure 6, no matter be drug releasing rate or drug accumulation release rate at a time, the system of HPMC all is greater than the system of blend polysaccharide, and this phenomenon has illustrated that the blend polysaccharide of KGM and XG has excellent drug blockage effect more.
Embodiment 7
Percentage composition takes by weighing 50% cimetidine, 25% lactose of crossing 100 purpose blend polysaccharide (KGM is 5:5 with the XG mixed proportion) and 25% and mixes and obtain mixture 1 by weight; The water that accounts for mixture 1 weight 30% is added wet granulation in the mixture 1, is dried to constant weight, cross 20 mesh sieve granulate; With the Pulvis Talci that accounts for particle weight 1% behind the granulate, 3% magnesium stearate is mixed, and is pressed into sustained-release matrix tablets again.Place the circular matrix tablet of the heavily about 1.0g of single punch tablet machine tablet forming at last, hardness 3-6kg/cm
2Measure the release of matrix tablet in the simulation gastro-intestinal Fluid.Experimental result shows, in simulated gastric fluid 2 hours, the drug accumulation release rate reaches 50%, in 3 hours subsequently simulated intestinal fluid, the drug accumulation release rate reaches 70%, compare the KGM:XG=5:5 system of identical preparation condition, drug release rate is slightly high, and this is owing to different mixture polysaccharide system polysaccharide interphase interaction difference causes.
A kind of preparation method of sustained-release matrix tablets, form by following step:
(1) percentage composition takes by weighing 20% cimetidine, 40% and crosses the starch of 100 purpose Rhizoma amorphophalli glucomannans, 10% xanthan gum and 30% and mix and obtain mixture 1 by weight;
(2) concentration expressed in percentage by volume that will account for mixture 1 weight 10% is that 30% ethanol water adds wet granulation in the mixture 1, is dried to constant weight, crosses 20 mesh sieve granulate; Again with account for granulate after the hydrogenated vegetable oil of particle weight 4% mix, be pressed into sustained-release matrix tablets.
Embodiment 9
A kind of preparation method of sustained-release matrix tablets, form by following step:
(1) percentage composition takes by weighing 80% cimetidine, 20% and crosses 100 purpose Rhizoma amorphophalli glucomannans and mix and obtain mixture 1 by weight;
(2) mass percentage concentration that will account for mixture 1 weight 40% is that 1% starch slurry adds wet granulation in the mixture 1, is dried to constant weight, crosses 20 mesh sieve granulate; Again with account for granulate after the magnesium stearate of particle weight 1% mix, be pressed into sustained-release matrix tablets.
A kind of preparation method of sustained-release matrix tablets, form by following step:
(1) percentage composition takes by weighing 40% metronidazole, 50% and crosses 100 purpose Rhizoma amorphophalli glucomannans, 5% xanthan gum by weight, and 5% Icing Sugar mixes and obtains mixture 1;
(2) mass percentage concentration that will account for mixture 1 weight 20% is that 15% methylcellulose adds wet granulation in the mixture 1, is dried to constant weight, crosses 20 mesh sieve granulate; Again with account for granulate after the Polyethylene Glycol of particle weight 2% mix, be pressed into sustained-release matrix tablets.
With the Icing Sugar in the alternative present embodiment of inorganic salt calcium sulfate, mannitol or sorbitol, also can form new embodiment and make sustained-release matrix tablets.
Embodiment 11
A kind of preparation method of sustained-release matrix tablets, form by following step:
(1) percentage composition takes by weighing 20% metronidazole, 20% and crosses 100 purpose Rhizoma amorphophalli glucomannans, 60% xanthan gum by weight, mixes obtaining mixture 1;
(2) mass percentage concentration that will account for mixture 1 weight 20% is that 15% polyvidone aqueous solution adds wet granulation in the mixture 1, is dried to constant weight, crosses 20 mesh sieve granulate; Again with account for granulate after the magnesium laurylsulfate of particle weight 2% mix, be pressed into sustained-release matrix tablets.
Embodiment 12
A kind of preparation method of sustained-release matrix tablets, form by following step:
(1) percentage composition takes by weighing 30% medicine, 30% and crosses 100 purpose Rhizoma amorphophalli glucomannans, 30% carrageenan by weight, and 10% amylum pregelatinisatum mixes and obtains mixture 1;
(2) mass percentage concentration that will account for mixture 1 weight 20% is that 15% aqueous gelatin solution adds wet granulation in the mixture 1, is dried to constant weight, crosses 20 mesh sieve granulate; Again with account for granulate after the magnesium laurylsulfate of particle weight 2% mix, be pressed into sustained-release matrix tablets.
It with concentration expressed in percentage by volume 5% or 10% ethanol water, mass percentage concentration is 1% or 5% starch slurry, mass percentage concentration is 1% hyprolose aqueous solution, mass percentage concentration is 5% hypromellose aqueous solution, mass percentage concentration is 10% sodium carboxymethyl cellulose solution, mass percentage concentration is 1% or 5% polyvidone aqueous solution, mass percentage concentration is 1% or 12% aqueous gelatin solution, mass percentage concentration is 1% or 15% Polyethylene Glycol aqueous solution, mass percentage concentration is that 50% aqueous sucrose solution or mass percentage concentration are that to substitute mass percentage concentration in the present embodiment be that 15% aqueous gelatin solution can be formed new embodiment for 1% or 5% or 10% Na-alginate aqueous solution.
Embodiment 13
A kind of preparation method of sustained-release matrix tablets, form by following step:
(1) percentage composition takes by weighing 20% medicine, 80% and crosses 100 purpose Rhizoma amorphophalli glucomannans and mix and obtain mixture 1 by weight;
(2) mass percentage concentration that will account for mixture 1 weight 40% is that 70% aqueous sucrose solution adds wet granulation in the mixture 1, is dried to constant weight, crosses 20 mesh sieve granulate; Again with account for granulate after the Polyethylene Glycol of particle weight 1% mix, be pressed into sustained-release matrix tablets.
Claims (10)
1. sustained-release matrix tablets is characterized in that being made by following step:
(1) percentage composition takes by weighing 20%-80% medicine, 20%-80% and crosses 100 purpose Rhizoma amorphophalli glucomannans, 0-60% xanthan gum or carrageenan by weight, and 0-30% mixing diluents obtains mixture 1;
(2) binding agent that will account for mixture 1 weight 10%-40% adds wet granulation in the mixture 1, is dried to constant weight, crosses 20 mesh sieve granulate; With the mix lubricant that accounts for particle weight 1%-4% behind the granulate, be pressed into sustained-release matrix tablets again.
2. a kind of sustained-release matrix tablets according to claim 1 is characterized in that described diluent is lactose, starch, Icing Sugar, amylum pregelatinisatum, inorganic salt, mannitol or sorbitol.
3. a kind of sustained-release matrix tablets according to claim 1 is characterized in that described binding agent is a water, concentration expressed in percentage by volume is the ethanol water of 5%-30%, mass percentage concentration is the starch slurry of 1%-15%, mass percentage concentration is the cellulose derivative aqueous solution of 1%-15%, mass percentage concentration is the polyvidone aqueous solution of 1%-15%, mass percentage concentration is the aqueous gelatin solution of 1%-15%, mass percentage concentration is the Polyethylene Glycol aqueous solution of 1%-15%, mass percentage concentration is the aqueous sucrose solution of 50%-70% or the Na-alginate aqueous solution that mass percentage concentration is 1%-10%.
4. a kind of sustained-release matrix tablets according to claim 3 is characterized in that described cellulose derivative is methylcellulose, hyprolose, hypromellose or sodium carboxymethyl cellulose.
5. a kind of sustained-release matrix tablets according to claim 1 is characterized in that described lubricant is that magnesium stearate, differential silica gel, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol and magnesium laurylsulfate are at least a.
6. the preparation method of a sustained-release matrix tablets is characterized in that being made up of following step:
(1) percentage composition takes by weighing 20%-80% medicine, 20%-80% and crosses 100 purpose Rhizoma amorphophalli glucomannans, 0-60% xanthan gum or carrageenan by weight, and 0-30% mixing diluents obtains mixture 1;
(2) binding agent that will account for mixture 1 weight 10-40% adds wet granulation in the mixture 1, is dried to constant weight, crosses 20 mesh sieve granulate; With the mix lubricant that accounts for particle weight 1%-4% behind the granulate, be pressed into sustained-release matrix tablets again.
7. the preparation method of a kind of sustained-release matrix tablets according to claim 6 is characterized in that described diluent is lactose, starch, Icing Sugar, amylum pregelatinisatum, inorganic salt, mannitol or sorbitol.
8. the preparation method of kind of sustained-release matrix tablets according to claim 6 is characterized in that described binding agent is a water, concentration expressed in percentage by volume is the ethanol water of 5%-30%, mass percentage concentration is the starch slurry of 1%-15%, mass percentage concentration is the cellulose derivative aqueous solution of 1%-15%, mass percentage concentration is the polyvidone aqueous solution of 1%-15%, mass percentage concentration is the aqueous gelatin solution of 1%-15%, mass percentage concentration is the Polyethylene Glycol aqueous solution of 1%-15%, mass percentage concentration is the aqueous sucrose solution of 50%-70% or the Na-alginate aqueous solution that mass percentage concentration is 1%-10%.
9. the preparation method of a kind of sustained-release matrix tablets according to claim 8 is characterized in that described cellulose derivative is methylcellulose, hyprolose, hypromellose or sodium carboxymethyl cellulose.
10. the method for a kind of sustained-release matrix tablets according to claim 6 is characterized in that described lubricant is that magnesium stearate, differential silica gel, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol and magnesium laurylsulfate are at least a.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101857647A (en) * | 2010-05-31 | 2010-10-13 | 北京理工大学 | Method for preparing floating konjac glucomannan (KGM) and application |
| CN102258494A (en) * | 2010-05-31 | 2011-11-30 | 北京理工大学 | Intra-gastric floating sustained-release tablets containing floating konjac glucomannan and preparation method thereof |
| CN103623413A (en) * | 2013-11-27 | 2014-03-12 | 广西大学 | Preparation method and application of controlled release carrier material of sucrose ester |
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2008
- 2008-12-19 CN CNA200810154290XA patent/CN101496793A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101857647A (en) * | 2010-05-31 | 2010-10-13 | 北京理工大学 | Method for preparing floating konjac glucomannan (KGM) and application |
| CN102258494A (en) * | 2010-05-31 | 2011-11-30 | 北京理工大学 | Intra-gastric floating sustained-release tablets containing floating konjac glucomannan and preparation method thereof |
| CN101857647B (en) * | 2010-05-31 | 2012-05-23 | 北京理工大学 | Method for preparing floating konjac glucomannan (KGM) and application |
| CN102258494B (en) * | 2010-05-31 | 2012-12-19 | 北京理工大学 | Intra-gastric floating sustained-release tablets containing floating konjac glucomannan and preparation method thereof |
| CN103623413A (en) * | 2013-11-27 | 2014-03-12 | 广西大学 | Preparation method and application of controlled release carrier material of sucrose ester |
| CN103623413B (en) * | 2013-11-27 | 2015-06-10 | 广西大学 | Preparation method and application of controlled release carrier material of sucrose ester |
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