CN104739794A - Novel potassium citrate sustained release tablet and preparation method thereof - Google Patents
Novel potassium citrate sustained release tablet and preparation method thereof Download PDFInfo
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- CN104739794A CN104739794A CN201310738258.7A CN201310738258A CN104739794A CN 104739794 A CN104739794 A CN 104739794A CN 201310738258 A CN201310738258 A CN 201310738258A CN 104739794 A CN104739794 A CN 104739794A
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- potassium citrate
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Abstract
The invention provides a novel potassium citrate sustained release tablet and a preparation method thereof, the preparation method comprises the steps of crushing, weighing raw materials, granulating, mixing and tabletting. The potassium citrate sustained release tablet comprises the following components: potassium citrate, a lipid material (monoglyceride stearate, glycerol distearates, glyceryl behenate, glyceryl palmitate-stearate, glycerol trilaurate, neodecanoic acid glyceride, stearic acid, palmitic acid, beeswax), lactose and microcrystalline cellulose. The potassium citrate sustained release tablet is prepared by the components by weight percentage: 1-50% of potassium citrate, 10-50% of lipid material, 10-70% of filler, 0-60% of wetting agent, 0.1-5% of adhesive and 0.1-2% of antitackiness agent. The potassium citrate sustained release tablet has the advantages of the quality is good, medicine release is alleviated, and biology utilization degree is increased.
Description
Technical field
The present invention relates to a kind of new potassium citrate sustained-release tablets and preparation method thereof, belong to pharmaceutical technology sectors.
Background technology
Potassium citrate (PotassiumCitrate), chemistry 2-hydroxy propane-1,2,3-carboxylic acid potassium by name, its molecular formula is C
6h
5k
30
7.H
2o, molecular weight is 324.41; Colourless crystallization or white crystalline powder, have and micro-ly draw moist, soluble in water, slow be dissolved in glycerol, be insoluble to alcohol, salty in the mouth and cool.
Urinary system calculus serious harm human health, according to its sickness rate of difference of geographical environment 3% ~ 15%, and sickness rate improves year by year, and easily recurrence after treatment, within 10 years, relapse rate is up to 50%.Potassium citrate sustained-release tablets starts clinical practice in 1985 in the U.S., it is a kind of powerful basifier, pass through alkalized urine, improve the excretion of urine citrate, reduce the formation of uric acid crystal, suppress the formation of calcium oxalate crystal, effectively can treat urinary system calculus, present domestic potassium citrate medication is based on potassium citrate granule, also potassium citrate oral liquid is seen, the dosage forms such as compound recipe potassium citrate total, domestic less about potassium citrate slow-releasing preparation report, granule medicining times is more, and slow releasing preparation effectively can reduce medicining times, maintain stable blood drug level, and potassium citrate is very easily water-soluble, thus slow releasing preparation is studied significant.
At present, being categorized as of sustained-release preparation: framework sustained controlling technology, osmotic pumps technology, film coating delay controlled-release technology, wherein again with the application of framework sustained controlling technology widely, framework sustained controlling technology be divided into hydrophilic gel skeleton, insoluble skeleton, film control skeleton, potassium citrate belongs to very easily water-soluble medicine, at present, the relevant report adopting erodible skeleton to prepare potassium citrate sustained-release tablets is not yet had.
Summary of the invention
The object of the invention is the defect filling up prior art, the novel potassium citrate sustained-release tablets that a kind of toxic and side effects is little, slow releasing medicine, bioavailability are high is provided.
Another object of the present invention is to provide the above-mentioned preparation method preparing potassium citrate sustained-release tablets using solid lipid material as framework material.
Prepare potassium citrate sustained-release tablets described in the present invention using solid lipid material as framework material and comprise the slow releasing tablet that medicine-containing particle and matrix material make, it is characterized in that slow releasing tablet is composed as follows:
(1) medicine-containing particle, the component containing, for example lower mass percentage:
(2) sustained-release matrix material, the component containing, for example lower mass percentage:
Matrix material 10% ~ 70%
Porogen 0% ~ 5%
Lipid backbone material percentage composition is with medicine-containing particle Weight computation.
A kind of new potassium citrate sustained-release tablets described in the present invention and preparation method thereof, wherein the particle size distribution of medicine-containing particle is 0.3 ~ 0.5mm, preferred 0.3-0.4mm.
A kind of new potassium citrate sustained-release tablets described in the present invention and preparation method thereof, the excipient wherein in medicine-containing particle is any one or multiple inactive material that pharmaceutics allows.
A kind of new potassium citrate sustained-release tablets described in the present invention and preparation method thereof, the matrix material wherein in medicine-containing particle is selected from glyceryl monostearate, glycerol distearate, glyceryl tristearate, Glyceryl Behenate, tripalmitin, palmitic acid stearic acid ester of glycerol, trilaurin, myristin, new certain herbaceous plants with big flowers acid glyceride, stearic acid, Palmic acid, any one of Cera Flava or two or more mixture.
A kind of new potassium citrate sustained-release tablets described in the present invention and preparation method thereof, the filler wherein in medicine-containing particle is selected from starch, lactose, dextrin, amylum pregelatinisatum, cellulose, sucrose, any one of mannitol or two or more mixture.
A kind of new potassium citrate sustained-release tablets described in the present invention and preparation method thereof, the binding agent wherein in medicine-containing particle is selected from starch, hypromellose, hydroxypropyl cellulose, carboxymethyl cellulose and sodium salt thereof, polyvinylpyrrolidone, any one of gelatin or two or more mixture.
A kind of new potassium citrate sustained-release tablets described in the present invention and preparation method thereof, the wetting agent wherein in medicine-containing particle is selected from water, ethanol, propylene glycol, glycerol, PEG400, Tweens, spans, any one of gathering propanol or two or more mixture.
A kind of new potassium citrate sustained-release tablets described in the present invention and preparation method thereof, the antiplastering aid wherein in medicine-containing particle is selected from magnesium stearate, micropowder silica gel, Pulvis Talci, titanium dioxide, silicon dioxide, polyethylene glycols, magnesium laurylsulfate, stearic acid, any one of sodium stearyl fumarate or two or more mixture.
A kind of new potassium citrate sustained-release tablets described in the present invention and preparation method thereof, is characterized in that described porogen is selected from methylcellulose, Polyethylene Glycol, polyvinylpyrrolidone, copolyvidone, sucrose, hypromellose, polymethacrylate, the cellulose phthalate element any one of class or two or more mixture.
A kind of new potassium citrate sustained-release tablets of the present invention and preparation method thereof, is characterized in that step is as follows:
Step 1: pulverize: the material pulverized needed for principal agent and filler, antiplastering aid is put into pulverizer respectively, machines, and powder is made the requirement reaching 80 mesh sieves;
Step 2: batch weighing: check according to preparation instruction sheet the supplementary material delivered to, carry out batch weighing;
Step 3: granulate: 1. wet granulation: matrix material/porogen is added wetting agent, heating, stirring/homogenizing makes it form lipid liquid, for subsequent use; Added by the material prepared in material machine processed, premix, adds this lipid liquid, stirs, and to be achievedly holds agglomerating, and the namely loose degree touched forms wet granular, namely can discharging; 2. dry granulation: add in mixer by the material prepared, mix homogeneously, discharging, granulates at granulator.
Step 4: dry: immediately granule to be placed in air-heating type drying baker, dry, discharging;
Step 5: granulate: dried granule is crossed 20-50 mesh sieve, with the granule of 20-50 mesh sieve for conforming particle;
Step 6: tabletting: according to sheeter operation code, carries out tabletting.
Compared with prior art, the present invention has following beneficial effect:
The invention provides and prepare potassium citrate sustained-release tablets using solid lipid material as framework material there is slow release effect, can medicine stability be strengthened, improve the bioavailability of medicine, reduce dosage, effectively reduce the accumulation of medicine, reduce toxic and side effects.
Compared with existing potassium citrate sustained-release tablets, the present invention adopts and prepares potassium citrate sustained-release tablets using solid lipid material as framework material.This technology, without the need to an organic solvent, can be prepared that medicine stability is good, bioavailability is high and have the potassium citrate sustained-release tablets of certain slow releasing function.
Accompanying drawing explanation
Fig. 1 is potassium citrate sustained-release tablets agent release curve.
Detailed description of the invention
The present invention is further illustrated below by way of detailed description of the invention.
Embodiment 1
Percentage ratio in prescription is the percentage by weight of this component shared by whole prescription, and matrix material percentage composition is with medicine-containing particle Weight computation, and following each embodiment is identical.
Prepare potassium citrate sustained-release tablets agent:
Step 1: pulverize: potassium citrate, microcrystalline Cellulose, hypromellose, Pulvis Talci are put into pulverizer respectively, machines, and powder is made the requirement reaching 80 mesh sieves;
Step 2: batch weighing: check according to preparation instruction sheet the supplementary material delivered to, carry out batch weighing;
Step 3: granulate: matrix material/porogen is added wetting agent, heating, stirring/homogenizing makes it form lipid liquid, for subsequent use; Added by the material prepared in material machine processed, premix, adds this lipid liquid, stirs, and to be achievedly holds agglomerating, and the namely loose degree touched forms wet granular, namely can discharging;
Step 4: dry: immediately granule to be placed in air-heating type drying baker, dry, discharging;
Step 5: granulate: dried granule is crossed 20-50 mesh sieve, with the granule of 20-50 mesh sieve for conforming particle;
Step 6: tabletting: according to sheeter operation code, carries out tabletting.
Heating-up temperature: 80 DEG C
Oven temperature: 55 DEG C.
Embodiment 2
Prepare potassium citrate sustained-release tablets agent:
Step 1: pulverize: potassium citrate, starch, hypromellose, Pulvis Talci are put into pulverizer respectively, machines, and powder is made the requirement reaching 80 mesh sieves;
Step 2: batch weighing: check according to preparation instruction sheet the supplementary material delivered to, carry out batch weighing;
Step 3: granulate: matrix material/porogen is added wetting agent, heating, stirring/homogenizing makes it form lipid liquid, for subsequent use; Added by the material prepared in material machine processed, premix, adds this lipid liquid, stirs, and to be achievedly holds agglomerating, and the namely loose degree touched forms wet granular, namely can discharging;
Step 4: dry: immediately granule to be placed in air-heating type drying baker, dry, discharging;
Step 5: granulate: dried granule is crossed 20-50 mesh sieve, with the granule of 20-50 mesh sieve for conforming particle;
Step 6: tabletting: according to sheeter operation code, carries out tabletting.
Heating-up temperature: 85 DEG C
Oven temperature: 50 DEG C.
Embodiment 3
Prepare potassium citrate sustained-release tablets agent:
Step 1: pulverize: potassium citrate, lactose, hypromellose, Pulvis Talci are put into pulverizer respectively, machines, and powder is made the requirement reaching 80 mesh sieves;
Step 2: batch weighing: check according to preparation instruction sheet the supplementary material delivered to, carry out batch weighing;
Step 3: granulate: matrix material/porogen is added wetting agent, heating, stirring/homogenizing makes it form lipid liquid, for subsequent use; Added by the material prepared in material machine processed, premix, adds this lipid liquid, stirs, and to be achievedly holds agglomerating, and the namely loose degree touched forms wet granular, namely can discharging;
Step 4: dry: immediately granule to be placed in air-heating type drying baker, dry, discharging;
Step 5: granulate: dried granule is crossed 20-50 mesh sieve, with the granule of 20-50 mesh sieve for conforming particle;
Step 6: tabletting: according to sheeter operation code, carries out tabletting.
Heating-up temperature: 80 DEG C
Oven temperature: 45 DEG C.
Embodiment 4
Prepare potassium citrate sustained-release tablets agent:
Step 1: pulverize: potassium citrate, microcrystalline Cellulose, polyvinylpyrrolidone, Pulvis Talci are put into pulverizer respectively, machines, and powder is made the requirement reaching 80 mesh sieves;
Step 2: batch weighing: check according to preparation instruction sheet the supplementary material delivered to, carry out batch weighing;
Step 3: granulate: matrix material/porogen is added wetting agent, heating, stirring/homogenizing makes it form lipid liquid, for subsequent use; Added by the material prepared in material machine processed, premix, adds this lipid liquid, stirs, and to be achievedly holds agglomerating, and the namely loose degree touched forms wet granular, namely can discharging;
Step 4: dry: immediately granule to be placed in air-heating type drying baker, dry, discharging;
Step 5: granulate: dried granule is crossed 20-50 mesh sieve, with the granule of 20-50 mesh sieve for conforming particle;
Step 6: tabletting: according to sheeter operation code, carries out tabletting.
Heating-up temperature: 82 DEG C
Oven temperature: 55 DEG C.
Embodiment 5
Prepare potassium citrate sustained-release tablets agent:
Step 1: pulverize: potassium citrate, microcrystalline Cellulose, hypromellose, Pulvis Talci are put into pulverizer respectively, machines, and powder is made the requirement reaching 80 mesh sieves;
Step 2: batch weighing: check according to preparation instruction sheet the supplementary material delivered to, carry out batch weighing;
Step 3: granulate: matrix material/porogen is added wetting agent, heating, stirring/homogenizing makes it form lipid liquid, for subsequent use; Added by the material prepared in material machine processed, premix, adds this lipid liquid, stirs, and to be achievedly holds agglomerating, and the namely loose degree touched forms wet granular, namely can discharging;
Step 4: dry: immediately granule to be placed in air-heating type drying baker, dry, discharging;
Step 5: granulate: dried granule is crossed 20-50 mesh sieve, with the granule of 20-50 mesh sieve for conforming particle;
Step 6: tabletting: according to sheeter operation code, carries out tabletting.
Heating-up temperature: 80 DEG C
Oven temperature: 50 DEG C.
Embodiment 6
Prepare potassium citrate sustained-release tablets agent:
Step 1: pulverize: potassium citrate, lactose, hypromellose, Pulvis Talci are put into pulverizer respectively, machines, and powder is made the requirement reaching 80 mesh sieves;
Step 2: batch weighing: check according to preparation instruction sheet the supplementary material delivered to, carry out batch weighing;
Step 3: granulate: matrix material/porogen is added wetting agent, heating, stirring/homogenizing makes it form lipid liquid, for subsequent use; Added by the material prepared in material machine processed, premix, adds this lipid liquid, stirs, and to be achievedly holds agglomerating, and the namely loose degree touched forms wet granular, namely can discharging;
Step 4: dry: immediately granule to be placed in air-heating type drying baker, dry, discharging;
Step 5: granulate: dried granule is crossed 20-50 mesh sieve, with the granule of 20-50 mesh sieve for conforming particle;
Step 6: tabletting: according to sheeter operation code, carries out tabletting.
Heating-up temperature: 85 DEG C
Oven temperature: 50 DEG C.
Embodiment 7
Prepare potassium citrate sustained-release tablets agent:
Step 1: pulverize: potassium citrate, lactose, hypromellose, Pulvis Talci are put into pulverizer respectively, machines, and powder is made the requirement reaching 80 mesh sieves;
Step 2: batch weighing: check according to preparation instruction sheet the supplementary material delivered to, carry out batch weighing;
Step 3: granulate: the material prepared is added in mixer, mix homogeneously, discharging, granulate at granulator.
Step 4: granulate: granule is crossed 20-50 mesh sieve, with the granule of 20-50 mesh sieve for conforming particle;
Step 5: tabletting: according to sheeter operation code, carries out tabletting.
Oven temperature: 50 DEG C.
The above embodiment only have expressed several embodiment of the present invention, and it describes comparatively concrete and detailed, but therefore can not be interpreted as the restriction to the scope of the claims of the present invention.It should be pointed out that for the person of ordinary skill of the art, without departing from the inventive concept of the premise, can also make some distortion and improvement, these all belong to protection scope of the present invention.Therefore, the protection domain of patent of the present invention should be as the criterion with claims.
Claims (9)
1. a potassium citrate sustained-release tablets, is characterized in that, slow releasing tablet comprises pastille slow-release granule, and slow-releasing granules is composed as follows:
(1) medicine-containing particle, the component containing, for example lower mass percentage:
(2) sustained-release matrix material, the component containing, for example lower mass percentage:
Matrix material 10% ~ 70%
Porogen 0% ~ 5%
Lipid backbone material percentage composition is with medicine-containing particle Weight computation.
2. a kind of potassium citrate sustained-release tablets as claimed in claim 1, it is characterized in that, described matrix material is selected from the mixture of any one or two or more arbitrary proportion in glyceryl monostearate, glycerol distearate, glyceryl tristearate, Glyceryl Behenate, tripalmitin, palmitic acid stearic acid ester of glycerol, trilaurin, myristin, new certain herbaceous plants with big flowers acid glyceride, stearic acid, Palmic acid, Cera Flava.
3. a kind of potassium citrate sustained-release tablets as claimed in claim 1, it is characterized in that, described binding agent is selected from the mixture of any one or two or more arbitrary proportion in starch, hypromellose, hydroxypropyl cellulose, carboxymethyl cellulose and sodium salt thereof, polyvinylpyrrolidone, gelatin, Polyethylene Glycol.
4. a kind of potassium citrate sustained-release tablets as claimed in claim 1, it is characterized in that, described antitackiness agent is selected from the mixture of any one or two or more arbitrary proportion in magnesium stearate, micropowder silica gel, Pulvis Talci, titanium dioxide, silicon dioxide, polyethylene glycols, magnesium laurylsulfate, stearic acid, sodium stearyl fumarate.
5. a kind of potassium citrate sustained-release tablets as claimed in claim 1, is characterized in that, described filler is selected from the mixture of any one or two or more arbitrary proportion in microcrystalline Cellulose, starch, Icing Sugar, dextrin, lactose, mannitol.
6. a kind of potassium citrate sustained-release tablets as claimed in claim 1, it is characterized in that, described wetting agent is selected from the mixture of any one or two or more arbitrary proportion in water, ethanol, propylene glycol, glycerol, PEG400, Tweens, spans, poly-propanol.
7. a kind of potassium citrate sustained-release tablets as claimed in claim 1, it is characterized in that, described porogen is selected from methylcellulose, Polyethylene Glycol, polyvinylpyrrolidone, copolyvidone, sucrose, hypromellose, polymethacrylate, the cellulose phthalate element any one of class or two or more mixture.
8. a preparation method for potassium citrate sustained-release tablets according to claim 1, is characterized in that, step is as follows:
Step 1: pulverize: the material pulverized needed for principal agent and filler, binding agent, antiplastering aid is put into pulverizer respectively, machines, and powder is made the requirement reaching 80 mesh sieves;
Step 2: batch weighing: check according to preparation instruction sheet the supplementary material delivered to, carry out batch weighing;
Step 3: granulate: 1. wet granulation: matrix material/porogen is added wetting agent, heating, stirring/homogenizing makes it form lipid liquid, for subsequent use; Added by the material prepared in material machine processed, premix, adds this lipid liquid, stirs, and to be achievedly holds agglomerating, and the namely loose degree touched forms wet granular, namely can discharging; 2. dry granulation: add in mixer by the material prepared, mix homogeneously, discharging, granulates at granulator.
Step 4: dry: immediately the granule of wet granulation to be placed in air-heating type drying baker, dry, discharging;
Step 5: granulate: dried granule is crossed 20-50 mesh sieve, with the granule of 20-50 mesh sieve for conforming particle;
Step 6: tabletting: according to sheeter operation code, carries out tabletting.
9. the preparation method of potassium citrate sustained-release tablets as claimed in claim 8, it is characterized in that, in step 5, granule crosses 20-50 mesh sieve.
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| CN112655969A (en) * | 2021-03-15 | 2021-04-16 | 江苏艾兰得营养品有限公司 | Choline bitartrate granules, tablets containing same and preparation method |
| WO2023272696A1 (en) * | 2021-07-01 | 2023-01-05 | 思瑰瑞保健食品有限公司 | Sustained-and-controlled-release potassium ion tablet and preparation method therefor |
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| CN112655969A (en) * | 2021-03-15 | 2021-04-16 | 江苏艾兰得营养品有限公司 | Choline bitartrate granules, tablets containing same and preparation method |
| WO2023272696A1 (en) * | 2021-07-01 | 2023-01-05 | 思瑰瑞保健食品有限公司 | Sustained-and-controlled-release potassium ion tablet and preparation method therefor |
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Application publication date: 20150701 |