CN103417535B - A kind of amoxicillin and clavulanate potassium tablets and preparation method thereof - Google Patents
A kind of amoxicillin and clavulanate potassium tablets and preparation method thereof Download PDFInfo
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- CN103417535B CN103417535B CN201310374575.5A CN201310374575A CN103417535B CN 103417535 B CN103417535 B CN 103417535B CN 201310374575 A CN201310374575 A CN 201310374575A CN 103417535 B CN103417535 B CN 103417535B
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Abstract
The invention discloses a kind of amoxicillin and clavulanate potassium tablets, in said preparation, the weight ratio of amoxicillin and clavulanate potassium is 4-8:1, described tablet by medicine-containing particle, clavulanate potassium, be dried to moisture lower than for 3% disintegrating agent and lubricant mix after direct compression form, described medicine-containing particle comprises the amoxicillin and tartaric acid that weight ratio is 1:0.1-0.5.Tablet stripping of the present invention is rapid, and good stability, supplementary product kind is few, and preparation technology is simple.
Description
Technical field
The invention belongs to medical art, in particular to a kind of amoxicillin and clavulanate potassium tablets and preparation method thereof.
Background technology
Amoxicillin, i.e. amoxycillin XiLin, be a kind of the most frequently used penicillins beta-lactam broad ectrum antibiotic, be white powder, the half-life is about 61.3min.Amoxicillin is stablized in acid condition, and gastrointestinal absorption rate reaches 90%, and its bactericidal action is strong, and energy is permeates cell membranes rapidly, is one of optimal drug being used for the treatment of animal breath systemic disease, pig hemophilus disease and puerperal infection at present.But amoxicillin is easily subject to the attack of beta-lactamase in body and is hydrolyzed, thus makes the effective blood drug concentration of amoxicillin reduce, and causes the drug resistance of various antibacterial to amoxicillin constantly to increase.Therefore, alone amoxicillin does not more and more reach expected effect to the various disease for the treatment of.In addition, can there is the degradation reaction of penicillin in amoxicillin, contains the carbonyl of the beta-lactam nucleus of free amine group side chain simultaneously, can make beta-lactam open loop polymerization reaction take place because of it.Very unstable under hot and humid condition, polymer obviously increases, and then may cause a series of anaphylaxis.
Clavulanate potassium is beta-lactamase inhibitor, and can be combined with beta-lactamase and generate irreversible conjugate, antibacterial activity own is more weak.Clavulanate potassium coordinates amoxicillin can significantly improve the antibacterial activity of amoxicillin and the penetration capacity of cell membrane thereof, and curative effect can increase several times even tens times, and Resistant strain can be made to recover responsive to medicine.Clavulanate potassium have draw by force moist, stability extreme difference, therefore when preparing amoxicillin and clavulanate potassium oral tablet, normally dry granulation, tabletting conveniently, after carrying out pretreatment by amoxicillin and clavulanate potassium, mix, through extruder extruding, broken, granulate, add disintegrating agent again, after lubricant always mixes, carry out tabletting.Although the method avoids wet granulation Problems existing, this technique length consuming time, its stability of the preparation of production is still not ideal enough.
Prior art also has a kind of method of direct compression, is directly pressed into tablet by pulverous material fine powder.But due to the mobility of the former medicated powder in amoxicillin and compressibility poor, easily produce the phenomenons such as top is split, sticking during direct compression, and tablet appearance product are also undesirable mutually.
CN101897701B discloses a kind of preparation method of amoxicillin and clavulanate potassium tablets, after being granulated amoxicillin, according to the mass ratio of 4:1, mixes with clavulanate potassium, forms major ingredient; Adjuvant micropowder silica gel, cross-linking sodium carboxymethyl cellulose and microcrystalline Cellulose are mixed according to equivalent method of progressively increasing, then progressively increases to drop in mixer with major ingredient equivalent and mix; Mixed powder is carried out tabletting.After former for amoxicillin powder is granulated, then mix homogeneously with clavulanate potassium, hence improve the mobility of major ingredient self, effectively prevent the phenomenons such as the top that direct compression produces is split, sticking.But this technology does not propose to adopt which kind of granulation mode, and how to improve the stability of clavulanate potassium.
CN100391456C disclose a kind of beta-cyclodextrin/amoxicillin inclusion compound and with the compositions of clavulanate potassium and preparation method.Cyclodextrin is mixed with water, makes into suspended substance, add amoxicillin, fully grind, cooling, filter, dry preparation solid clathrates after solids washing.But amoxicillin is beta-lactam structure, is easily hydrolyzed, adopting cyclodextrin inclusion technique, take water as medium, and the stability of amoxicillin is difficult to ensure.
CN101502511A provides a kind of amoxicillin/clavulanate and 8:1 sheet and preparation method thereof, has selected the 8:1 of amoxicillin and clavulanate potassium to mix powder, adopts dry granulation process.Equally, the not mentioned stability problem how solving amoxicillin and clavulanate potassium of this technology.
Summary of the invention
In view of the polyreaction of amoxicillin is mainly because side-chain amino group attack beta-lactam nucleus causes, if certain technological means can be adopted to avoid this reaction to occur, improve amoxicillin stability in the formulation by being expected to.In addition, clavulanate potassium has and draws by force moist, affects, will greatly improve its stability in the formulation if reduce moisture on it.
The object of the invention is to, by preparation prescription research experiment, provide the amoxycillin-potassium clavulanate tablets preparation that a kind of good stability, dissolution are high.In order to realize object of the present invention, inventor is surprised to find that in a large amount of experimental studies, after adding tartaric acid, not only can improve drug dissolution, and can increase substantially the stability of amoxicillin in preparation prescription.In addition, introduce and be dried to moisture lower than for after the disintegrating agent of 3%, because of the easier moisture absorption of disintegrating agent, therefore moisture is captured by this this adjuvant, protects clavulanate potassium from moisture effects.
Specifically, the object of the present invention is achieved like this:
A kind of amoxicillin and clavulanate potassium tablets, the weight ratio of amoxicillin and clavulanate potassium is 4-8:1, described tablet by medicine-containing particle, clavulanate potassium, be dried to moisture lower than for 3% disintegrating agent and lubricant mix after direct compression form, described medicine-containing particle comprises the amoxicillin and tartaric acid that weight ratio is 1:0.1-0.5.
Preferably, above-mentioned amoxicillin and clavulanate potassium tablets, wherein said medicine-containing particle is that the amoxicillin of 1:0.1-0.5 and tartaric acid form by weight ratio.
Further preferably, above-mentioned amoxicillin and clavulanate potassium tablets, wherein said medicine-containing particle is sieved in amoxicillin and tartaric acid mix rear wet granulation and obtain.
Again further preferably, above-mentioned amoxicillin and clavulanate potassium tablets, the binding agent in wherein said wet granulation is dehydrated alcohol.
Amoxicillin and clavulanate potassium tablets of the present invention, the consumption of wherein said disintegrating agent accounts for the 3-10% of whole weight, is selected from following one or more: polyvinylpolypyrrolidone, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose.
Further preferably, above-mentioned amoxicillin and clavulanate potassium tablets, wherein said disintegrating agent is polyvinylpolypyrrolidone, and consumption accounts for the 5-8% of whole weight.
Amoxicillin and clavulanate potassium tablets of the present invention, wherein said lubricant is magnesium stearate or Pulvis Talci.
Another object of the present invention is the preparation method providing a kind of above-mentioned amoxicillin and clavulanate potassium tablets, and the method comprises the steps:
(1) 80-100 mesh sieve is crossed respectively in amoxicillin and tartaric acid, mix homogeneously, adds dehydrated alcohol wet granulation, 16-18 mesh sieve granulate, and 45-50 DEG C of drying, obtains medicine-containing particle, for subsequent use;
(2) by disintegrating agent in 105 DEG C of dryings, being dried to moisture lower than being 3%, under relative humidity is less than 45%RH condition, being chilled to room temperature, cross 80 mesh sieves, for subsequent use;
(3) under relative humidity is less than 45%RH condition, clavulanate potassium is crossed 80 mesh sieves, for subsequent use;
(4) by medicine-containing particle with sieve after disintegrating agent and clavulanate potassium mix homogeneously, add lubricant, mixing after direct compression.
Preferably, the preparation method of above-mentioned amoxicillin and clavulanate potassium tablets, the consumption of wherein said disintegrating agent accounts for the 3-10% of whole weight, is selected from following one or more: polyvinylpolypyrrolidone, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose.
Preferably, the preparation method of above-mentioned amoxicillin and clavulanate potassium tablets, wherein said lubricant is magnesium stearate or Pulvis Talci.
Because tartaric acid is soluble in water, tartaric acid is added in amoxicillin and clavulanate potassium tablets, utilize the character that it is soluble in water, use as porogen when dissolution determination, not only improve the dissolution velocity of medicine, and the tartaric acid dissolved reduces the acidity of aqueous solution, further increases drug solubility; What is more important; after adding tartaric acid; the stability of amoxicillin obtains beyond thought raising; even if under comparatively exacting terms; polymer does not also change substantially, may be tartaric acid as carboxylic acid, after fully contacting with amoxicillin; protect the carbonyl of amoxicillin lactam nucleus, hinder the attack of the amino on amoxicillin to lactam nucleus.In addition, introduce in prescription of the present invention and be dried to moisture lower than for after the disintegrating agent of 3%, because of the easier moisture absorption of disintegrating agent, therefore moisture is captured by this this adjuvant, protects clavulanate potassium from moisture effects.In a word, compared with prior art, the amoxicillin and clavulanate potassium tablets supplementary product kind consumption that the present invention relates to is few, preparation technology is simple, and the slice, thin piece outward appearance of preparation is good, unilateral bright and clean, stripping is rapid, and after accelerating investigation, amoxicillin polymer, related substance do not increase substantially.
Detailed description of the invention
Following examples further describe preparation process of the present invention and beneficial effect, embodiment is only for the object of illustration, do not limit the scope of the invention, the simultaneously apparent change made according to the present invention of those of ordinary skill in the art and modification are also contained within the scope of the invention.
Embodiment 1 amoxicillin and clavulanate potassium tablets and preparation technology thereof
Preparation technology:
(1) 100 mesh sieves are crossed respectively in amoxicillin and tartaric acid, mix homogeneously, adds dehydrated alcohol wet granulation, 16 mesh sieve granulate, and 50 DEG C of dryings, obtain medicine-containing particle, for subsequent use;
(2) by disintegrating agent in 105 DEG C of dryings, being dried to moisture is 2.6%, under relative humidity is less than 45%RH condition, is chilled to room temperature, cross 80 mesh sieves, for subsequent use;
(3) under relative humidity is less than 45%RH condition, clavulanate potassium is crossed 80 mesh sieves, for subsequent use;
(4) by medicine-containing particle with sieve after polyvinylpolypyrrolidone and clavulanate potassium mix homogeneously, add magnesium stearate, mixing after direct compression.
Embodiment 2 amoxicillin and clavulanate potassium tablets and preparation technology thereof
Preparation technology:
(1) 80 mesh sieves are crossed respectively in amoxicillin and tartaric acid, mix homogeneously, adds dehydrated alcohol wet granulation, 18 mesh sieve granulate, and 45 DEG C of dryings, obtain medicine-containing particle, for subsequent use;
(2) by disintegrating agent in 105 DEG C of dryings, being dried to moisture is 2.9%, under relative humidity is less than 45%RH condition, is chilled to room temperature, cross 80 mesh sieves, for subsequent use;
(3) under relative humidity is less than 45%RH condition, clavulanate potassium is crossed 80 mesh sieves, for subsequent use;
(4) by medicine-containing particle with sieve after polyvinylpolypyrrolidone and clavulanate potassium mix homogeneously, add magnesium stearate, mixing after direct compression.
Embodiment 3 amoxicillin and clavulanate potassium tablets and preparation technology thereof
Preparation technology:
(1) 100 mesh sieves are crossed respectively in amoxicillin and tartaric acid, mix homogeneously, adds dehydrated alcohol wet granulation, 18 mesh sieve granulate, and 45 DEG C of dryings, obtain medicine-containing particle, for subsequent use;
(2) by disintegrating agent in 105 DEG C of dryings, being dried to moisture lower than being 2.8%, under relative humidity is less than 45%RH condition, being chilled to room temperature, cross 80 mesh sieves, for subsequent use;
(3) under relative humidity is less than 45%RH condition, clavulanate potassium is crossed 80 mesh sieves, for subsequent use;
(4) by medicine-containing particle with sieve after polyvinylpolypyrrolidone and clavulanate potassium mix homogeneously, add magnesium stearate, mixing after direct compression.
Comparative example 1 amoxicillin and clavulanate potassium tablets and preparation technology thereof
Preparation technology:
(1) 100 mesh sieves are crossed in amoxicillin, mix homogeneously, add dehydrated alcohol wet granulation, 18 mesh sieve granulate, 45 DEG C of dryings, obtain medicine-containing particle, for subsequent use;
(2) by disintegrating agent in 105 DEG C of dryings, being dried to moisture lower than being 2.8%, under relative humidity is less than 45%RH condition, being chilled to room temperature, cross 80 mesh sieves, for subsequent use;
(3) under relative humidity is less than 45%RH condition, clavulanate potassium is crossed 80 mesh sieves, for subsequent use;
(4) by medicine-containing particle with sieve after polyvinylpolypyrrolidone and clavulanate potassium mix homogeneously, add magnesium stearate, mixing after direct compression.
Comparative example 2 amoxicillin and clavulanate potassium tablets and preparation technology thereof
Preparation technology:
(1) 100 mesh sieves are crossed respectively in amoxicillin and citric acid, mix homogeneously, adds dehydrated alcohol wet granulation, 18 mesh sieve granulate, and 45 DEG C of dryings, obtain medicine-containing particle, for subsequent use;
(2) by disintegrating agent in 105 DEG C of dryings, being dried to moisture lower than being 2.8%, under relative humidity is less than 45%RH condition, being chilled to room temperature, cross 80 mesh sieves, for subsequent use;
(3) under relative humidity is less than 45%RH condition, clavulanate potassium is crossed 80 mesh sieves, for subsequent use;
(4) by medicine-containing particle with sieve after polyvinylpolypyrrolidone and clavulanate potassium mix homogeneously, add magnesium stearate, mixing after direct compression.
Comparative example 3 amoxicillin and clavulanate potassium tablets and preparation technology thereof
Preparation technology:
(1) 100 mesh sieves are crossed respectively in amoxicillin and tartaric acid, mix homogeneously, adds dehydrated alcohol wet granulation, 18 mesh sieve granulate, and 45 DEG C of dryings, obtain medicine-containing particle, for subsequent use;
(2) polyvinylpolypyrrolidone is crossed 80 mesh sieves, for subsequent use;
(3) under relative humidity is less than 45%RH condition, clavulanate potassium is crossed 80 mesh sieves, for subsequent use;
(4) by medicine-containing particle with sieve after polyvinylpolypyrrolidone and clavulanate potassium mix homogeneously, add magnesium stearate, mixing after direct compression.
The stability of embodiment 4 amoxycillin-potassium clavulanate tablets and dissolution investigate test
1, dissolution detects
The amoxycillin-potassium clavulanate tablets prepared of Example 1-3 and comparative example 1-3 respectively, according to dissolution method (annex XC second method), with water 900ml for dissolution medium, rotating speed is 75 turns per minute, operate in accordance with the law, through 30 minutes time, get solution appropriate, filter, get subsequent filtrate as need testing solution; Another precision take amoxicillin reference substance and clavulanate reference substance in right amount each, to be dissolved in water and quantitatively dilution makes the mixed solution identical with need testing solution concentration, product solution in contrast.Measure according to the method under assay item, calculate the stripping quantity of amoxicillin and clavulanic acid in every sheet respectively.Limit is 80% of labelled amount, all should conform with the regulations.
2, assay
Measure according to high performance liquid chromatography (annex VD).Chromatographic condition and system suitability octadecylsilane chemically bonded silica are filler; Be mobile phase with 0.05mol/L sodium dihydrogen phosphate (get sodium dihydrogen phosphate 7.8g, the 900ml that adds water makes dissolving, with 10% phosphoric acid solution or sodium hydroxide test solution adjust ph to 4.4 ± 0.1, is diluted with water to 1000ml)-methanol (95:5); Determined wavelength is 220nm.Get amoxicillin and clavulanate system suitability reference substance, add mobile phase and dissolve and dilute the solution made about containing 0.8mg in every lml, get 20 μ 1 note people chromatograph of liquid, the chromatogram of record should be consistent with standard diagram.
Algoscopy.The amoxycillin-potassium clavulanate tablets 10 prepared of Example 1-3 and comparative example 1-3 respectively, accurately weighed, porphyrize, precision takes in right amount (being about equivalent to average sheet weight), add water appropriate, ultrasonicly make dissolving and quantitatively the solution containing amoxicillin 0.5mg in every lml is made in dilution, filter, precision measures subsequent filtrate 20 μ 1 note people chromatograph of liquid immediately, record chromatogram; Another precision take amoxicillin reference substance and clavulanate reference substance in right amount each, to be dissolved in water and quantitatively the mixed solution identical with need testing solution concentration is made in dilution, to be measured in the same method.Calculate respectively with peak area by external standard method.
3, related substance
The fine powder of amoxycillin-potassium clavulanate tablets prepared of Example 1-3 and comparative example 1-3 is appropriate respectively, add mobile phase A dissolve (ice-bath ultrasonic 5-10 minute if desired hydrotropy) and dilute the solution made containing amoxicillin 2mg in every lml, filter, get subsequent filtrate as need testing solution; Precision measures in right amount, quantitatively dilutes the solution made containing amoxicillin 40 μ g in every 1ml, solution in contrast by mobile phase A.Measuring according to high performance liquid chromatography (annex VD), is filler with octadecylsilane chemically bonded silica (A type); Mobile phase A is 0.01mol/L potassium dihydrogen phosphate (by 2mol/L sodium hydroxide solution adjust ph to 6.0), and Mobile phase B is 0.01mol/L potassium dihydrogen phosphate (by 2mol/L sodium hydroxide solution adjust ph to 6.0)-acetonitrile (20:80); Determined wavelength is 230nm; First with mobile phase A-Mobile phase B (98:2) isocratic elution, treat that according to the form below carries out linear gradient elution immediately after peak, amoxicillin eluting.The retention time at peak, amoxicillin is about 10 minutes, get amoxicillin and clavulanate system suitability reference substance, add mobile phase A dissolve and dilute the solution made about containing 2.5mg in every lml, get 20 μ l and note people's chromatograph of liquid, the chromatogram of record should be consistent with standard diagram.Get contrast solution 20 μ 1 injection liquid chromatography, regulate detection sensitivity, make the peak height at peak, amoxicillin be about 25% of full scale; Precision measures need testing solution and each 20 μ 1 of contrast solution again, notes people's chromatograph of liquid respectively, record chromatogram.If any impurity peaks in need testing solution chromatogram, each impurity peak area and must not be greater than contrast solution two main peak area and 1.5 times (3.0%), in need testing solution chromatogram, can ignore in any peak being less than contrast solution two main peak area and 0.05 times.Gradient elution is according to table 1.
Table 1 condition of gradient elution
| Time (minute) | Mobile phase A (%) | Mobile phase B (%) |
| 0 | 98 | 2 |
| 20 | 70 | 30 |
| 22 | 98 | 2 |
| 32 | 98 | 2 |
4, polymer determination:
Chromatographic condition and system suitability: with sephadex G-10(40-120 μm) be filler, glass column internal diameter 1.3-1.6cm, post height 30-40cm.With pH8.0 phosphate buffer [0.05mol/L sodium hydrogen phosphate-0.05mol/L sodium dihydrogen phosphate (95:5)] for mobile phase A, take water as Mobile phase B, flow velocity is 1.5ml per minute, and determined wavelength is 254nm.Respectively with mobile phase A, B for mobile phase, get 0.1mg/ml blue dextran 2000 solution 200 μ l injection liquid chromatography, number of theoretical plate by blue dextran 2000 peak calculate all be not less than 700.Tailing factor all should be less than 2.0.In two kinds of flow phase system blue Portugal get the ratio of sugared 2000 peak retention times should between 0.93-1.07, in contrast solution main peak and need testing solution, in polymer peak and corresponding chromatographic system, the ratio of the retention time at blue dextran 2000 peak all should between 0.93-1.07.Another is mobile phase with Mobile phase B, and precision measures contrast solution 200 μ l, continuous sample introduction 5 times, and the relative standard deviation of peak area should be not more than 5.0%.
The preparation of contrast solution: get penicillin reference substance appropriate, accurately weighed, be dissolved in water and quantitatively dilute the solution made about containing 0.2mg in every 1ml.
Algoscopy: the amoxycillin-potassium clavulanate tablets that respectively prepared by Example 1-3 and comparative example 1-3 is about 0.2g, accurately weighed, put in 10ml measuring bottle, add 2% sodium carbonate liquor 4ml and make dissolving, be diluted with water to scale, shake up, precision measures 200 μ l injecting chromatographs immediately, be that mobile phase measures with mobile phase A, record chromatogram.Another precision measures contrast solution 200 μ l injecting chromatograph, is mobile phase, is measured in the same method with Mobile phase B.By external standard method with calculated by peak area, containing amoxicillin polymer in amoxicillin, must not 0.2% be crossed.
The each embodiment product of table 20 day measurement result
The each embodiment product of table 3 accelerates measurement result after 6 months (acceleration environment: 40 DEG C, 75%RH)
Above-mentioned result of the test shows, amoxycillin-potassium clavulanate tablets prepared by the embodiment of the present invention 1-3 result through accelerating to investigate is its good stability, and stripping is fast; Not tartarize in the prescription of comparative example 1, result aggregator thing, related substance increase obviously, and dissolution is also poor; Adopt citric acid to replace tartaric acid in the prescription of comparative example 2, dissolution is better, but the content of polymer, related substance increases very fast, less stable; In comparative example 3, polyvinylpolypyrrolidone is moist, and related substance increases obviously, and content declines to a great extent, and may be the ability that polyvinylpolypyrrolidone does not have deprives moisture, when tablet is under the condition of high humidity, caused by clavulanate potassium degraded.
Claims (9)
1. an amoxicillin and clavulanate potassium tablets, the weight ratio of amoxicillin and clavulanate potassium is 4-8:1, it is characterized in that: described tablet by medicine-containing particle, clavulanate potassium, be dried to moisture lower than for 3% disintegrating agent and lubricant mix after direct compression form, described medicine-containing particle is that the amoxicillin of 1:0.1-0.5 and the tartaric acid wet granulation after mixing that sieves obtains by weight ratio.
2. amoxicillin and clavulanate potassium tablets according to claim 1, is characterized in that: described medicine-containing particle is that the amoxicillin of 1:0.1-0.5 and tartaric acid form by weight ratio.
3. amoxicillin and clavulanate potassium tablets according to claim 1 and 2, is characterized in that: the binding agent in described wet granulation is dehydrated alcohol.
4. amoxicillin and clavulanate potassium tablets according to claim 1 and 2, it is characterized in that: the consumption of described disintegrating agent accounts for the 3-10% of whole weight, be selected from following one or more: polyvinylpolypyrrolidone, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose.
5. amoxicillin and clavulanate potassium tablets according to claim 4, is characterized in that: described disintegrating agent is polyvinylpolypyrrolidone, and consumption accounts for the 5-8% of whole weight.
6. amoxicillin and clavulanate potassium tablets according to claim 1 and 2, is characterized in that: described lubricant is magnesium stearate or Pulvis Talci.
7. the preparation method of amoxicillin and clavulanate potassium tablets according to claim 1 or 2, is characterized in that the method comprises the steps:
(1) 80-100 mesh sieve is crossed respectively in amoxicillin and tartaric acid, mix homogeneously, adds dehydrated alcohol wet granulation, 16-18 mesh sieve granulate, and 45-50 DEG C of drying, obtains medicine-containing particle, for subsequent use;
(2) by disintegrating agent in 105 DEG C of dryings, being dried to moisture lower than being 3%, under relative humidity is less than 45%RH condition, being chilled to room temperature, cross 80 mesh sieves, for subsequent use;
(3) under relative humidity is less than 45%RH condition, clavulanate potassium is crossed 80 mesh sieves, for subsequent use;
(4) by medicine-containing particle with sieve after disintegrating agent and clavulanate potassium mix homogeneously, add lubricant, mixing after direct compression.
8. the preparation method of amoxicillin and clavulanate potassium tablets according to claim 7, it is characterized in that: the consumption of described disintegrating agent accounts for the 3-10% of whole weight, be selected from following one or more: polyvinylpolypyrrolidone, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose.
9. the preparation method of amoxicillin and clavulanate potassium tablets according to claim 7, is characterized in that: described lubricant is magnesium stearate or Pulvis Talci.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101161233A (en) * | 2007-11-29 | 2008-04-16 | 湖北丽益医药科技有限公司 | Ebstine solid oral preparation and its preparing method |
| CN101890004A (en) * | 2009-05-18 | 2010-11-24 | 北京瑞伊人科技发展有限公司 | Amoxicillin/potassium clavulanate sustained-release preparation composition and preparation method thereof |
| CN101897701A (en) * | 2009-05-27 | 2010-12-01 | 华北制药集团制剂有限公司 | Preparation method of amoxicillin and clavulanate potassium tablets |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101161233A (en) * | 2007-11-29 | 2008-04-16 | 湖北丽益医药科技有限公司 | Ebstine solid oral preparation and its preparing method |
| CN101890004A (en) * | 2009-05-18 | 2010-11-24 | 北京瑞伊人科技发展有限公司 | Amoxicillin/potassium clavulanate sustained-release preparation composition and preparation method thereof |
| CN101897701A (en) * | 2009-05-27 | 2010-12-01 | 华北制药集团制剂有限公司 | Preparation method of amoxicillin and clavulanate potassium tablets |
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