CN101502511A - Amoxicillin/clavulanate potassium tablet and preparation method thereof - Google Patents
Amoxicillin/clavulanate potassium tablet and preparation method thereof Download PDFInfo
- Publication number
- CN101502511A CN101502511A CNA2008102122807A CN200810212280A CN101502511A CN 101502511 A CN101502511 A CN 101502511A CN A2008102122807 A CNA2008102122807 A CN A2008102122807A CN 200810212280 A CN200810212280 A CN 200810212280A CN 101502511 A CN101502511 A CN 101502511A
- Authority
- CN
- China
- Prior art keywords
- amoxicillin
- clavulanate potassium
- clavulanate
- preparation
- lactose
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention provides an amoxicillin/clavulanate (8:1) tablet and a preparation method thereof. The amoxicillin/clavulanate (8:1) tablet has the advantages of simple preparation process, good quality controllability and stability and low forming-production cost by adopting the mixed amoxicillin/clavulanate (8:1) intermediate materials having good quality controllability and stability as the main drug resource.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of amoxicillin/clavulanate potassium 8:1 sheet and preparation method thereof.
Background technology
The amoxicillin/clavulanate potassium compound preparation is that the amoxicillin becomes to be grouped into for two kinds with clavulanate potassium, is the severe infection one line infection medication efficiently of the anti-enzyme of clinical common wide spectrum.Wherein, the amoxicillin is a penbritin class beta-lactam semisynthetic antibiotics, and mechanism of action is suppress bacteria cell wall synthetic, has bactericidal action fast, and is effective to most of grams and positive bacteria and negative bacterium, but easily by the beta-lactam enzymatic degradation; Clavulanate potassium is a beta-lactamase inhibitor, itself has only faint antibacterial activity, can control in a large number penicillin and cephalosporin there be the avtive spot of the beta-lactamase in the chemical sproof microorganism and make its inactivation, thereby have powerful wide spectrum lactamase inhibitory action.The combined is used, but the antagonism beta-lactamase is to the destruction of amoxicillin, to improve therapeutic effect.
The antimicrobial spectrum of this product is identical with the amoxicillin, and enlarges to some extent.To producing enzyme staphylococcus aureus, staphylococcus epidermidis, coagulase negative staphylococcus and the equal tool good action of enterococcus, some intestinal liver Cordycepps antibacterial, hemophilus influenza, moraxelle catarrhalis, bacteroides fragilis etc. that produce beta-lactamase also there is better antibacterial activity.This product does not have effect to the enterobacteriaceae lactobacteriaceae and the Rhodopseudomonas of product chromosomes such as methicillin-resistant staphylococcus and Enterobacter mediation I type enzyme.
According to reports, amoxicillin/clavulanate potassium this product is stable to gastric acid, and oral absorption is good, and food does not have obvious influence to the absorption of this product.Empty stomach oral this product 375mg (amoxicillin 250mg and clavulanic acid 125mg), the amoxicillin reached blood peak concentration of drug (Cmax) in 1.5 hours, be about 5.6mg/L, and blood elimination half-life (t1/2b) is about 1 hour, and the urine discharge rate was 50%～78% in 8 hours; The pharmacokinetic parameters of clavulanic acid is identical with single time spent, reaches blood peak concentration of drug (Cmax) in 1 hour behind the oral clavulanic acid 125g of normal person, is about 3.4mg/L.Protein binding rate is 22%～30%.It is 0.76～1.4 hour that blood is eliminated the half-life (t1/2b), and the urine discharge rate was about 46% in 8 hours.Both are respectively 97% and 75% at oral bioavailability.
Acidproof, the anti-enzyme of this product is applicable to lower respiratory infection, otitis media, the sinusitis of producing due to enzyme hemophilus influenza and the moraxelle catarrhalis; Respiratory tract, urinary tract and skin soft-tissue infection etc. due to product enzyme staphylococcus aureus and product enzyme enterobacteriaceae lactobacteriaceae such as escherichia coli, the Klebsiella; Also can be used for the light grade and moderate infection due to the enterococcus.This product also can be used for the above-mentioned various infection due to the responsive not zymogenic bacteria.
At present, the amoxicillin/clavulanate potassium compound recipe ratio of approved listing both at home and abroad has 2:1,4:1 and 7:1; Commercially available except that the aseptic powder injection, peroral dosage forms such as dry syrup, tablet (ordinary tablet, chewable tablet, dispersible tablet), granule, dry suspension are still arranged.
Because the clavulanic acid price is more expensive, man of producer competitively develops the preparation of low ratio clavulanic acid both at home and abroad, there are some researches show: in amoxicillin and clavulanate 2:1, the 4:1 preparation, clavulanic acid to press down the enzyme rate close substantially, its curative effect is basically identical also.Even the clavulanic acid consumption is reduced to 1/10 o'clock of amoxicillin, also can obtain 52% press down the enzyme rate.Amoxicillin/clavulanate potassium 8:1 sheet (every contains amoxicillin 500mg, clavulanate potassium 62.5mg) though the clavulanic acid consumption is reduced to 1/8 of amoxicillin in these product, can not reduce its antibiotic curative effect yet.In addition, usage of this product and amoxicillin and clavulanate 7:1 (every contains amoxicillin 400mg, clavulanate potassium 57mg) are identical, because amoxicillin content obtains increasing among the former, so therapeutic effect will be above the latter.
Amoxicillin/clavulanate potassium, its chemical name is respectively: (2S, 5R, 6R)-3, (-) 2-amino-2-(4-hydroxy phenyl) acetylamino of 3-dimethyl-6-[(R)]-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-formic acid trihydrate and (Z)-(2S, 5R)-3-(2-hydroxyl ethylidene)-7-oxo-4-oxa--1-azabicyclo [3.2.0] heptane-2-carboxylic acid potassium.Amoxicillin and clavulanate potassium are and draw moist stronger material, and unstable and degrade in the aqueous solution, and temperature, oxidant, some heavy metal ion are all to its catalytic action of having degraded.These self-characteristics of amoxicillin, clavulanate potassium, bring following difficult point can for the preparation moulding process of the compound preparation medicine of its various ratios: because amoxicillin and clavulanate potassium different proportion are along with increasing proportioning (especially vast scale), easily moisture absorption degraded, easy influence factors such as high temperature destruction, make the mixing homogeneity in the mixing of materials operation be difficult to hold, this moulding process quality control to preparations such as tablets has also increased difficulty; Simultaneously, in order to obtain up-to-standard related preparations, certainly will cause the production control cost to increase (the improvement input of high low humidity, the production environment of low temperature, the use of special installation causes percent defective increase etc. because of incomplete mixing).
In preparation tablets research, meet at mixed material under the assurance of homogeneous quality requirement, searching out compatibility relevant auxiliary materials good and that safety is good is the key that preparation prescription is formed, the appropriate process technology is shaped preparation and the key that is easy to production operation.
At the solution of amoxicillin/clavulanate potassium compound preparation processing difficulties, the domestic related application that several pieces of distinct methods are arranged.All the seeing of at present relevant patent situation retrieval, application number: 200410083987.4, a kind of pharmaceutical composition that contains Utimox and clavulanate potassium; Application number: 00510039175.4, beta-cyclodextrin/amoxicillin inclusion compound and with the compositions and the preparation method of clavulanate potassium; Application number: 200610033852.6, a kind of preparation contains the method for the medicinal mixture of Amoxicillin Sodium and clavulanate potassium; Application number: 200610045718.8, amoxicillin-potsssium clavulanate dispersion tablet; Application number: 96195022.6, contain the compositions of amoxicillin and clavulanic acid; Application number: 98804095.6, contain the pharmaceutical preparation of amoxicillin and Clavulanate; Application number: 200710306511.6, a kind of antibiotic medicine that contains amoxicillin nano granule and clavulanate potassium.Wherein, 98804095.6 invention, contain that existing narration can realize this purpose by the common semi-finished product granule that application contains fixed proportion amoxicillin and Clavulanate among the pharmaceutical preparation of amoxicillin and Clavulanate, relevant pharmaceutic adjuvant and GB 2005538-A (Beecham Gro promptly), WO 95/28927 (Smithkline Beecham), the WO 95/25516 (Smithkline Beecham), the final preparation of different proportion is realized having in the amoxicillin that adds appropriate amount by the final step in method then.
But these methods all must earlier be molded into granule with amoxicillin and clavulanate potassium respectively with the amoxicillin powder, but also need diluent such as a certain amount of microcrystalline Cellulose of adding, micropowder silica gel.
In addition, in order to store safely and to transport, clavulanate potassium mixes with diluent silica gel, microcrystalline Cellulose, is generally the ratio of 1:1.The further like this complexity that increases preparation technology, and contain the tablet that the clavulanate potassium be made up of the mixture of clavulanate potassium above-mentioned and diluent 1:1 is made, because the absolute magnitude of medicine has increased, so the tablet size also increased, and this makes this tablet be difficult to swallow.
This just needs a kind of more effective amoxicillin/clavulanate 8:1 method for preparing tablet thereof of design.We have developed amoxicillin/clavulanate potassium 8:1 sheet and preparation method thereof through exploring repeatedly and studying.In the method for the present invention, prepare amoxicillin/clavulanate potassium 8:1 tablet, can make the commercial production summary, controlledization of end product quality by blended stock in the middle of the amoxicillin/clavulanate potassium (8:1) of using uniformity system easy to control the quality.Simultaneously, we search out relevant auxiliary materials and the appropriate process technology that the compatibility is good and safety is good and prepare amoxicillin/clavulanate potassium 8:1 tablet, make the tablet molding be easy to production operation, and the stability of product and quality controllability are good.
Show through relevant patent and prior art literature search result, there is no the relevant report of the relevant preparation of the present invention amoxicillin/clavulanate potassium 8:1 tablet.
Summary of the invention
In order to save amoxicillin/clavulanate preparation cost, and overcome a series of problems in the amoxicillin/clavulanate potassium formulation preparation of bringing because of the defective of amoxicillin, clavulanate potassium self physico-chemical property, the invention provides amoxicillin/clavulanate potassium 8:1 sheet and preparation method thereof.In the method for the present invention, prepare amoxicillin/clavulanate potassium 8:1 tablet, can make the commercial production summary, controlledization of end product quality by blended stock in the middle of the amoxicillin/clavulanate potassium (8:1) of using uniformity system easy to control the quality.Simultaneously, we have used relevant auxiliary materials that the compatibility is good and safety is good and appropriate process technology to prepare amoxicillin/clavulanate potassium 8:1 tablet, make the tablet molding be easy to production operation, and the stability of product and quality controllability are good.
The objective of the invention is to carry one for kind of amoxicillin/clavulanate potassium 8:1 sheet and preparation method thereof.
The objective of the invention is to realize by following concrete scheme.
The present invention selects suitable, clinical adjuvant safe in utilization to make " amoxicillin/clavulanate potassium 8:1 sheet " on the basis that with blended stock in the middle of the amoxicillin/clavulanate potassium (8:1) of uniformity system easy to control the quality is being amoxicillin, clavulanate potassium principal agent source.
Because amoxicillin and clavulanate potassium different proportion are along with increasing influence factors such as proportioning (especially vast scale), easily moisture absorption degraded, easy high temperature destruction, make the mixing homogeneity in the mixing of materials operation be difficult to hold, this moulding process quality control to preparations such as tablets has also increased difficulty; Simultaneously, in order to obtain up-to-standard related preparations, certainly will cause the production control cost to increase (the improvement input of high low humidity, the production environment of low temperature, the use of special installation, cause percent defective increase etc. because of incomplete mixing), therefore we adopt that blended stock is amoxicillin, clavulanate potassium principal agent source in the middle of the amoxicillin/clavulanate potassium (8:1) of uniformity system easy to control the quality, can make the tablet molding be easy to production operation like this, the stability of product, quality controllability are good, and tablet molding production cost is low.
Amoxicillin/clavulanate potassium 8:1 sheet of the present invention, this tablet contains following composition by weight percentage:
Blended stock is 100 parts in the middle of the amoxicillin/clavulanate potassium (8:1)
0～30 part of filler
0～30 part of disintegrating agent
0～30 part of binding agent
0～40 part of other adjuvant
Lubricant 0～5%;
Amoxicillin/clavulanate potassium 8:1 sheet specification: amoxicillin/clavulanate is 500mg/62.5mg, 250mg/31.25mg.
Amoxicillin/clavulanate potassium 8:1 sheet preparation technology: it is standby that filler, disintegrating agent, binding agent and other adjuvant etc. that blended stock and molding are used in the middle of the amoxicillin/clavulanate potassium (8:1) are crossed 80 mesh sieves respectively, get filler, disintegrating agent, binding agent and other adjuvant etc. that blended stock and molding are used in the middle of the amoxicillin/clavulanate potassium (8:1) of recipe quantity then and put mixing in the blender, place the press dry-pressing to granulate, cross 16 mesh sieve granulate, weigh, add the recipe quantity lubricant, tabletting, coating are promptly.
Described other adjuvant can be fluidizer, solvent etc.
Described solvent can be in dehydrated alcohol, acetone, the dichloromethane etc. one or more.
Described filler can be selected more than a kind or a kind of crystallized mannitol, lactose, amylum pregelatinisatum, microcrystalline Cellulose, calcium sulfate etc. for use.
Described disintegrating agent can select for use low substituted hydroxy-propyl methylcellulose, polyvinylpolypyrrolidone, microcrystalline Cellulose, starch and derivant thereof etc. more than a kind or a kind.
Described binding agent can be selected from the following material one or more: amylum pregelatinisatum, low substituted hydroxy-propyl methylcellulose, polyvinylpyrrolidone, lactose etc.
Described lubricant can be selected from the following material one or more: Pulvis Talci, magnesium stearate, micropowder silica gel etc.
We serve as that prescription screens supplementary product kind, consumption and technology with the screening index of technology with flowability, outward appearance, compressibility, disintegrate.Supplementary product kind, consumption and technology such as the following table 1 of having screened:
Supplementary product kind, consumption and the technology of table 1 screening
| The prescription numbering | 1 | 2 | 3 | 4 |
| Blended stock (mg) in the middle of the amoxicillin/clavulanate potassium (8:1) | 562.5 | 562.5 | 562.5 | 562.5 |
| Microcrystalline Cellulose (mg) | 200 | 100 | 100 | 100 |
| Low substituted hydroxy-propyl methylcellulose (mg) | -- | 50 | 50 | 50 |
| Crospolyvinylpyrrolidone (mg) | 30 | 30 | 40 | 60 |
| Lactose (mg) | -- | 50 | 50 | 50 |
| Magnesium stearate | -- | 1％ | 0.5％ | 0.5％ |
| The coating weightening finish | -- | 3％ | 3％ | 3％ |
| Technical process | Direct compression | The dehydrated alcohol wet granulation | Dry pressing is granulated | Dry pressing is granulated |
Prescription and craft screening the results are shown in Table 2.
Table 2 prescription and craft screening result
| The prescription numbering | 1 | 2 | 3 | 4 |
| Mobile | Difference, 54 ° of angle of reposes | Better, 32 ° of angle of reposes | Better, 30 ° of angle of reposes | Better, 31 ° of angle of reposes |
| Outward appearance | Relatively poor, the corner is irregular | Better, bright and clean attractive in appearance | Good, bright and clean attractive in appearance | Bright and clean attractive in appearance |
| Compressibility | Compressibility is brought up, and medicated powder is too dry and astringent | Compressibility is good, and slice is smooth, and is no longer dry and astringent | Compressibility is good | Compressibility is good |
| Disintegrate | — | Cross slow, greater than 15 minutes | Slower, about 8 minutes | Better, about 5 minutes |
According to prescription and craft screening result, drawing prescription 4 and technology thereof is the optimal preparation scheme of amoxicillin/clavulanate potassium 8:1 sheet, that is:
Prescription:
The coating prescription:
Preparation technology:
It is standby that blended stock, microcrystalline Cellulose, low substituted hydroxy-propyl methylcellulose, crospolyvinylpyrrolidone, lactose, magnesium stearate in the middle of the amoxicillin/clavulanate potassium (8:1) are crossed 80 mesh sieves respectively, get the middle blended stock of amoxicillin/clavulanate potassium (8:1), microcrystalline Cellulose, low substituted hydroxy-propyl methylcellulose, crospolyvinylpyrrolidone, the lactose of recipe quantity then and put mixing in the blender, place the press dry-pressing to granulate, cross 16 mesh sieve granulate, weigh, add the recipe quantity magnesium stearate, tabletting, coating are promptly.
According to the practical condition and the biological nature in pharmaceutical factory, this prescription adopts dry pressing to granulate, and adds the magnesium stearate tabletting.Easily the oxidation jaundice is rotten because principal agent is exposed in the air, therefore wrap moisture resistance type film-coat after, can avoid this situation to take place, because of principal agent to water, thermo-responsive, coating solution adopts the dehydrated alcohol preparation, dry this process adopts cold wind to dry up in the coating process.
Adding the low substituted hydroxy-propyl methylcellulose and both can improve its compressibility, is again excellent disintegrating agent and binding agent simultaneously.The microcrystalline Cellulose of selecting for use can make the slice, thin piece easy-formation, and hardness meets the requirements; Lactose can make unilateral bright and clean, and can improve the compressibility of slice, thin piece.Select for use magnesium stearate can avoid sticking phenomenon in the tabletting process, but double as fluidizer simultaneously improve particulate flowability as lubricant.
Amoxicillin/clavulanate potassium 8:1 piece preparation method of the present invention, molding is easy to production operation, and the stability of product and quality controllability are good, and the molding production cost is low.
The specific embodiment
Embodiment 1
Prescription:
The coating prescription:
Preparation technology:
Mistake 80 mesh sieves are standby respectively with amoxicillin/clavulanate potassium (8:1) centre blended stock, crystallized mannitol, low substituted hydroxy-propyl methylcellulose, crospolyvinylpyrrolidone, lactose, magnesium stearate to get recipe quantity; Get the middle blended stock of amoxicillin/clavulanate potassium (8:1), crystallized mannitol, low substituted hydroxy-propyl methylcellulose, crospolyvinylpyrrolidone, lactose mixing in blender of recipe quantity then; Get above mixed powder, place the press rolling process to granulate, cross 16 mesh sieve granulate, weigh, admix the recipe quantity magnesium stearate, evenly mixed, be pressed into every plain sheet that contains amoxicillin 500mg, clavulanic acid 62.5mg; The employing Opadry is a coating material, is mixed with coating solution with dehydrated alcohol and to plain coating tablets plain sheet is weighed about 2-3%.
Zhi Bei amoxicillin/clavulanate potassium 8:1 sheet as stated above meets the requirement of coherent detection project of regulation in " Chinese Pharmacopoeia 2005 version two ones " ' rules of preparations '.
Embodiment 2
Prescription:
The coating prescription:
Preparation technology:
Mistake 80 mesh sieves are standby respectively with amoxicillin/clavulanate potassium (8:1) centre blended stock, amylum pregelatinisatum, low substituted hydroxy-propyl methylcellulose, crospolyvinylpyrrolidone, lactose, magnesium stearate to get recipe quantity; Get the middle blended stock of amoxicillin/clavulanate potassium (8:1), amylum pregelatinisatum, low substituted hydroxy-propyl methylcellulose, crospolyvinylpyrrolidone, lactose mixing in blender of recipe quantity then; Get above mixed powder, place the press rolling process to granulate, cross 16 mesh sieve granulate, weigh, admix the recipe quantity magnesium stearate, evenly mixed, be pressed into every plain sheet that contains amoxicillin 500mg, clavulanic acid 62.5mg; The employing Opadry is a coating material, is mixed with coating solution with dehydrated alcohol and to plain coating tablets plain sheet is weighed about 2-3%.
Zhi Bei amoxicillin/clavulanate potassium 8:1 sheet as stated above meets the requirement of coherent detection project of regulation in " Chinese Pharmacopoeia 2005 version two ones " ' rules of preparations '.
Embodiment 3
Prescription:
The coating prescription:
Preparation technology:
Mistake 80 mesh sieves are standby respectively with amoxicillin/clavulanate potassium (8:1) centre blended stock, amylum pregelatinisatum, low substituted hydroxy-propyl methylcellulose, crospolyvinylpyrrolidone, lactose, micropowder silica gel to get recipe quantity; Get the middle blended stock of amoxicillin/clavulanate potassium (8:1), amylum pregelatinisatum, low substituted hydroxy-propyl methylcellulose, crospolyvinylpyrrolidone, lactose, micropowder silica gel mixing in blender of recipe quantity then; Get above mixed powder, place the press rolling process to granulate, cross 16 mesh sieve granulate, weigh, be pressed into every plain sheet that contains amoxicillin 500mg, clavulanic acid 62.5 mg; The employing Opadry is a coating material, is mixed with coating solution with dehydrated alcohol and to plain coating tablets plain sheet is weighed about 2-3%.
Zhi Bei amoxicillin/clavulanate potassium 8:1 sheet as stated above meets the requirement of coherent detection project of regulation in " Chinese Pharmacopoeia 2005 version two ones " ' rules of preparations '.
Embodiment 4
Prescription:
The coating prescription:
Preparation technology:
It is standby that 80 mesh sieves are crossed in blended stock, microcrystalline Cellulose, low substituted hydroxy-propyl methylcellulose, crospolyvinylpyrrolidone, amylum pregelatinisatum, micropowder silica gel in the middle of the amoxicillin/clavulanate potassium (8:1) respectively; Get the middle blended stock of amoxicillin/clavulanate potassium (8:1), microcrystalline Cellulose, low substituted hydroxy-propyl methylcellulose, crospolyvinylpyrrolidone, amylum pregelatinisatum, micropowder silica gel mixing in blender of recipe quantity then; Get above mixed powder, place the press rolling process to granulate, cross 16 mesh sieve granulate, weigh, be pressed into every plain sheet that contains amoxicillin 250mg, clavulanic acid 31.25mg; The employing Opadry is a coating material, is mixed with coating solution with anhydrous propanone and to plain coating tablets plain sheet is weighed about 2-3%.
Zhi Bei amoxicillin/clavulanate potassium 8:1 sheet as stated above meets the requirement of coherent detection project of regulation in " Chinese Pharmacopoeia 2005 version two ones " ' rules of preparations '.
Claims (8)
1, a kind of amoxicillin/clavulanate potassium 8:1 sheet and preparation method thereof, it is characterized in that: this tablet contains following composition by weight percentage:
Blended stock is 100 parts in the middle of the amoxicillin/clavulanate potassium (8:1)
0～30 part of filler
0～30 part of disintegrating agent
0～30 part of binding agent
0～40 part of other adjuvant
Lubricant 0～5%;
Amoxicillin/clavulanate potassium 8:1 sheet specification: amoxicillin/clavulanate is 500mg/62.5mg, 250mg/31.25mg;
Preparation technology: it is standby that filler, disintegrating agent, binding agent and other adjuvant etc. that blended stock in the middle of the amoxicillin/clavulanate potassium (8:1) and molding are used are crossed 80 mesh sieves respectively, get filler, disintegrating agent, binding agent and other adjuvant etc. that blended stock and molding are used in the middle of the amoxicillin/clavulanate potassium (8:1) of recipe quantity then and put mixing in the blender, place the press dry-pressing to granulate, cross 16 mesh sieve granulate, weigh, add the recipe quantity lubricant, tabletting, coating are promptly.
2,, it is characterized in that it can be fluidizer, solvent etc. according to described other adjuvant of claim 1.
3,, it is characterized in that it can be in dehydrated alcohol, acetone, the dichloromethane etc. one or more according to the described solvent of claim 2.
4, filler according to claim 1 is characterized in that: filler can be selected crystallized mannitol, lactose, amylum pregelatinisatum, microcrystalline Cellulose, calcium sulfate etc. a kind or multiple for use.
5, disintegrating agent according to claim 1 is characterized in that: disintegrating agent can be selected a kind or multiple of low substituted hydroxy-propyl methylcellulose, polyvinylpolypyrrolidone, microcrystalline Cellulose, starch and derivant thereof etc. for use.
6, binding agent according to claim 1 is characterized in that: binding agent is selected from one or more in the following material: amylum pregelatinisatum, low substituted hydroxy-propyl methylcellulose, polyvinylpyrrolidone, lactose etc.
7, lubricant according to claim 1 is characterized in that: lubricant can be selected from one or more in the following material: Pulvis Talci, magnesium stearate, micropowder silica gel etc.
8, amoxicillin/clavulanate potassium 8:1 sheet according to claim 1, it is preferably write out a prescription and preparation technology is: prescription:
The coating prescription:
Preparation technology:
It is standby that blended stock, microcrystalline Cellulose, low substituted hydroxy-propyl methylcellulose, crospolyvinylpyrrolidone, lactose, magnesium stearate in the middle of the amoxicillin/clavulanate potassium (8:1) are crossed 80 mesh sieves respectively, get the middle blended stock of amoxicillin/clavulanate potassium (8:1), microcrystalline Cellulose, low substituted hydroxy-propyl methylcellulose, crospolyvinylpyrrolidone, the lactose of recipe quantity then and put mixing in the blender, place the press dry-pressing to granulate, cross 16 mesh sieve granulate, weigh, add the recipe quantity magnesium stearate, tabletting, coating are promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008102122807A CN101502511A (en) | 2008-09-09 | 2008-09-09 | Amoxicillin/clavulanate potassium tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008102122807A CN101502511A (en) | 2008-09-09 | 2008-09-09 | Amoxicillin/clavulanate potassium tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101502511A true CN101502511A (en) | 2009-08-12 |
Family
ID=40974972
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2008102122807A Pending CN101502511A (en) | 2008-09-09 | 2008-09-09 | Amoxicillin/clavulanate potassium tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101502511A (en) |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102240285A (en) * | 2011-04-21 | 2011-11-16 | 南京仕必得生物技术有限公司 | Amoxicillin and potassium clavulanate tablet for dogs and cats, and its preparation method and application |
| CN103340855A (en) * | 2013-07-16 | 2013-10-09 | 上海汉维生物医药科技有限公司 | Compound amoxicillin and clavulanate potassium tablet and preparation method thereof |
| CN104473922A (en) * | 2013-07-16 | 2015-04-01 | 上海汉维生物医药科技有限公司 | Compound tablet and preparation method thereof |
| CN104546838A (en) * | 2013-07-16 | 2015-04-29 | 上海汉维生物医药科技有限公司 | Tablet and preparation method thereof |
| CN109248150A (en) * | 2017-07-13 | 2019-01-22 | 鲁南制药集团股份有限公司 | A kind of amoxicillin and clavulanate potassium preparation and preparation method thereof |
| CN111377947A (en) * | 2018-12-29 | 2020-07-07 | 江苏先声药业有限公司 | Amoxicillin trihydrate pharmaceutical composition with low water activity and preparation method thereof |
| CN114869884A (en) * | 2021-07-30 | 2022-08-09 | 江苏恒丰强生物技术有限公司 | Compound amoxicillin powder for porcine respiratory diseases and preparation method thereof |
-
2008
- 2008-09-09 CN CNA2008102122807A patent/CN101502511A/en active Pending
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102240285A (en) * | 2011-04-21 | 2011-11-16 | 南京仕必得生物技术有限公司 | Amoxicillin and potassium clavulanate tablet for dogs and cats, and its preparation method and application |
| CN103340855A (en) * | 2013-07-16 | 2013-10-09 | 上海汉维生物医药科技有限公司 | Compound amoxicillin and clavulanate potassium tablet and preparation method thereof |
| CN103340855B (en) * | 2013-07-16 | 2015-01-07 | 上海汉维生物医药科技有限公司 | Compound amoxicillin and clavulanate potassium tablet and preparation method thereof |
| CN104473922A (en) * | 2013-07-16 | 2015-04-01 | 上海汉维生物医药科技有限公司 | Compound tablet and preparation method thereof |
| CN104546838A (en) * | 2013-07-16 | 2015-04-29 | 上海汉维生物医药科技有限公司 | Tablet and preparation method thereof |
| CN104546838B (en) * | 2013-07-16 | 2018-05-01 | 上海汉维生物医药科技有限公司 | Tablet and preparation method thereof |
| CN109248150A (en) * | 2017-07-13 | 2019-01-22 | 鲁南制药集团股份有限公司 | A kind of amoxicillin and clavulanate potassium preparation and preparation method thereof |
| CN109248150B (en) * | 2017-07-13 | 2020-07-21 | 鲁南制药集团股份有限公司 | Amoxicillin and clavulanate potassium preparation and preparation method thereof |
| CN111377947A (en) * | 2018-12-29 | 2020-07-07 | 江苏先声药业有限公司 | Amoxicillin trihydrate pharmaceutical composition with low water activity and preparation method thereof |
| CN111377947B (en) * | 2018-12-29 | 2022-10-21 | 江苏先声药业有限公司 | Amoxicillin trihydrate pharmaceutical composition with low water activity and preparation method thereof |
| CN114869884A (en) * | 2021-07-30 | 2022-08-09 | 江苏恒丰强生物技术有限公司 | Compound amoxicillin powder for porcine respiratory diseases and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101502511A (en) | Amoxicillin/clavulanate potassium tablet and preparation method thereof | |
| CN101732277A (en) | Stable sitafloxacin medicinal composition and preparation method thereof | |
| CN103623412B (en) | Stable cefaclor tablet composition and preparation method thereof | |
| CN101190217A (en) | Amoxicillin clavulanate potassium 4:1 dispersible tablet and production technology thereof | |
| CN102258495B (en) | Cefprozil tablet and preparation method thereof | |
| CN113476406A (en) | Veterinary compound amoxicillin powder and preparation process thereof | |
| CN101890004A (en) | Amoxicillin/potassium clavulanate sustained-release preparation composition and preparation method thereof | |
| CN103520124B (en) | A kind of Levofloxacin Tablet and preparation method thereof | |
| CN101890006A (en) | Amoxicillin sustained-release preparation composition and preparation method thereof | |
| CN103191114A (en) | Moxifloxacin-containing oral drug solid preparation and preparation method thereof | |
| CN109248150B (en) | Amoxicillin and clavulanate potassium preparation and preparation method thereof | |
| CN101612138B (en) | Cefetamet pivoxil hydrochloride capsule and preparation method thereof | |
| CN103145733B (en) | Amoxicillin compound and pharmaceutical composition of amoxicillin compound and potassium clavulanate | |
| CN113116840A (en) | Preparation method of hydroxychloroquine sulfate tablet | |
| CN102861015B (en) | Stable amoxicillin and clavulanate potassium sustained release preparation and preparation technology | |
| CN104688701A (en) | Cefaclor tablet and preparation method thereof | |
| CN113662919B (en) | Stable cefixime tablet and preparation method thereof | |
| CN101862307A (en) | Bisulfate Cefdinir sodium capsule and preparation method thereof | |
| CN102228448B (en) | Cefuroxime axetil tablet and direct all-powder compression method thereof | |
| CN104173310A (en) | Stable amoxicillin tablet composition, as well as preparation method and application thereof | |
| CN103479589A (en) | Cefpodoxime proxetil dispersible tablet and preparation method thereof | |
| CN104940204A (en) | Ticagrelor solid preparation and preparation method thereof | |
| CN101889989A (en) | Amoxicillin enteric controlled-release preparation composite and preparation method thereof | |
| CN111377947B (en) | Amoxicillin trihydrate pharmaceutical composition with low water activity and preparation method thereof | |
| CN101890005A (en) | Amoxicillin/clavulanate potassium enteric-coated preparation composition and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20090812 |