CN1846702A - Dispersed cefditoren pivoxil tablet and its prepn process - Google Patents
Dispersed cefditoren pivoxil tablet and its prepn process Download PDFInfo
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- CN1846702A CN1846702A CN 200610050672 CN200610050672A CN1846702A CN 1846702 A CN1846702 A CN 1846702A CN 200610050672 CN200610050672 CN 200610050672 CN 200610050672 A CN200610050672 A CN 200610050672A CN 1846702 A CN1846702 A CN 1846702A
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- cefditoren pivoxil
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Abstract
The present invention relates to cefditoren pivoxil preparation, and is especially dispersed cefditoren pivoxil tablet suitable for children, old people and patient dysphagia of sensitive organism infection and its preparation process. The dispersed cefditoren pivoxil tablet consists of cefditoren pivoxil in 50-150 weight portions, microcrystalline cellulose in 10-500 weight portions, cross-linking polyvidone in 5-50 weight portions, proteoglycan in 5-50 weight portions, 3 % concentration hypromellose solution in proper amount and magnesium stearate in 0.5-5 weight portions. The preparation process includes sieving material, mixing, pelletizing, drying, pressing into tablet and other steps. The dispersed cefditoren pivoxil tablet has the advantages of fast disintegration in water, good taste, high stability, high bioavailability, etc.
Description
Technical field
The present invention relates to a kind of novel formulation of Cefditoren pivoxil Cephalosporins, be specially adapted to dispersible tablet of child, old man that a cefditoren ester sensitive organism is infected and the Cefditoren pivoxil Cephalosporins that can not swallow the solid preparation patient and preparation method thereof.
Background technology
Cefditoren pivoxil Cephalosporins MingZhi fruit Co., Ltd exploitation the 4th generation cephalosporin medicament, its chemical structural formula is:
Molecular formula: C
25H
28N
6O
7S
3
Molecular weight: 620.73
The Cefditoren pivoxil Cephalosporins English name is cefditoren pivoxil, chemical name: (-)-(6R, 7R)-2,2-dimethyl propylene acyl-oxygen methyl 7-[(Z)-2-(2-amino-4-thiazolyl)-2-methoxyl group imido acetylamino]-3-[(Z)-2-(4-methyl-5-thiazole base) vinyl]-8-oxo-5-thia-1-azabicyclic [4,2,0] suffering-2-carboxylate, G+ and G-bacterium had extensive antibacterial action, especially to staphylococcus, the G+ bacterium such as Streptococcus that comprise streptococcus pneumoniae, escherichia coli, branhamella catarrhalis, Kleb, Proteus, gram-negative bacteria and Peptostreptococcuses such as hemophilus influenza, propionibacterium acnes, the beta-lactamase that anaerobe such as Bacteroides produce is stable, beta-lactamase is produced strain also show very strong antimicrbial power.The mechanism of action of cefditoren is synthetic for suppressing bacteria cell wall, with the affinity height of various antibacterial penicillin-binding proteins (PBP), and the performance bactericidal action.
The development of these product is by Japan Patent, clear 59-186464, and denomination of invention: " novel cephalosporin compounds ", patent protection period is mistake.The domestic sale that the Cefditoren pivoxil Cephalosporins tablet is only arranged at present, so dosage form is single, can not satisfy dissimilar patients' medication demand, particularly child, old man and to taking the patient of solid preparation such as tablet difficulty, the new application method of developing these product satisfies these patients' medication demand, effectively improves patient's compliance of taking medicine and shows necessary especially.Dispersed cefditoren pivoxil tablet is not seen research and listing report both at home and abroad as yet.
Summary of the invention
The preparation that the purpose of this invention is to provide a kind of new Cefditoren pivoxil Cephalosporins, it is dispersible tablet that contains Cefditoren pivoxil Cephalosporins and preparation method thereof, can satisfy dissimilar patients' medication demand, can be in water disintegrate and form uniform suspension solution rapidly, it is good to have mouthfeel, steady quality, bioavailability advantages of higher, child, old man and the patient that can not swallow solid preparation can be applicable to especially, this part patient's medication compliance can be effectively improved.
Its main component is medicine and at least a disintegrating agent and meets water and form compatibility such as full-bodied swelling adjuvant and form, and meets water disintegrate and form uniform suspension solution rapidly, and difficult old man and child have brought very big convenience to swallowing.Can effectively improve this part patient's medication compliance.
The present invention relates to a kind of new dispersed cefditoren pivoxil tablet, by principal agent---Cefditoren pivoxil Cephalosporins, filler, disintegrating agent and correctives mix, through granulation, forced air drying, granulate, total mixing, tabletting makes dispersed cefditoren pivoxil tablet.
The present invention relates to a kind of preparation method of new dispersed cefditoren pivoxil tablet, by Cefditoren pivoxil Cephalosporins, microcrystalline Cellulose, polyvinylpolypyrrolidone, protein sugar, hypromellose solution, magnesium stearate is formed, supplementary material is crossed 100 mesh sieves, take by weighing hypromellose, add water and make 3% solution, standby, take by weighing the recipe quantity Cefditoren pivoxil Cephalosporins, microcrystalline Cellulose, protein sugar and recipe quantity polyvinylpolypyrrolidone, mix homogeneously adds 3% hypromellose solution and makes soft material in right amount, through granulating, forced air drying, granulate adds residue polyvinylpolypyrrolidone and magnesium stearate, total mixing, tabletting makes.
The present invention relates to a kind of dispersed cefditoren pivoxil tablet, be made up of following parts by weight material: 50～150 parts of Cefditoren pivoxil Cephalosporins, 10～500 parts of microcrystalline Cellulose, 5～50 parts of polyvinylpolypyrrolidone, 5～50 parts of protein sugar, 3% hypromellose solution are an amount of, 0.5～5 part of magnesium stearate.
The concrete preparation method of dispersed cefditoren pivoxil tablet of the present invention is as follows:
(1) gets the raw materials ready
According to the composition and the proportioning of product get the raw materials ready (parts by weight)
50～150 parts of Cefditoren pivoxil Cephalosporins
10～500 parts of microcrystalline Cellulose
5～50 parts of crosslinked poly-dimensions
5～50 parts of protein sugar
3% hypromellose solution is an amount of
0.5～5 part of magnesium stearate
(2) granulation, tabletting
Supplementary material is crossed 100 mesh sieves, takes by weighing hypromellose, adds water and makes 3% solution, and is standby.Take by weighing recipe quantity Cefditoren pivoxil Cephalosporins, microcrystalline Cellulose, protein sugar and half recipe quantity polyvinylpolypyrrolidone, mix homogeneously adds 3% hypromellose solution and makes soft material in right amount, 20 orders are granulated, 60 ℃ of forced air dryings, 24 order granulate, add residue polyvinylpolypyrrolidone and magnesium stearate, total mixed, tabletting.
The preparation technology of dispersed cefditoren pivoxil tablet of the present invention follows these steps to finish:
1. supplementary material is crossed 100 mesh sieves.
2. take by weighing hypromellose, add water and make 3% solution, standby.
3. take by weighing recipe quantity Cefditoren pivoxil Cephalosporins, microcrystalline Cellulose, protein sugar and half recipe quantity polyvinylpolypyrrolidone, mix homogeneously adds 3% hypromellose solution and makes soft material in right amount, 20 orders are granulated, 60 ℃ of forced air dryings, 24 order granulate, add residue polyvinylpolypyrrolidone and magnesium stearate, total mixing.
4. sampling, intermediate detects.
5. tabletting is packed.
6. inspection entirely, warehouse-in.
Dispersed cefditoren pivoxil tablet, its filler comprises microcrystalline Cellulose, starch, lactose, dextrin, mannitol, but is not limited to above-mentioned filler.
Dispersed cefditoren pivoxil tablet, its disintegrating agent comprises polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, carboxymethyl starch sodium, pregelatinized Starch, but is not limited to above-mentioned disintegrating agent.
Dispersed cefditoren pivoxil tablet, its correctives comprise protein sugar, stevioside, saccharin sodium, aspartame, sweet close element, flavoring orange essence, Fructus Citri Limoniae essence but are not limited to above-mentioned correctives.
Dispersed cefditoren pivoxil tablet of the present invention and preparation method thereof has following beneficial effect:
(1) dispersed cefditoren pivoxil tablet of the present invention is to improve by dosage form to form on the basis of Cefditoren pivoxil Cephalosporins sheet, is mixed with by principal agent and specific disintegrating agent and correctives to form, and mouthfeel is better, steady quality.
(2) dispersed cefditoren pivoxil tablet good absorbing of the present invention.It is compared with conventional tablet, and disintegrate becomes homodisperse granule rapidly in water, and the stripping that helps medicine absorbs, and therefore, oral post-absorption is fast, the bioavailability height.
(3) the dispersed cefditoren pivoxil tablet of the present invention patient that is specially adapted to child, old man and can not swallows solid preparation can effectively improve this part patient's medication compliance.
Description of drawings
Fig. 1 is a process chart of the present invention.
Fig. 2 is serum drug level a---time plot.
The specific embodiment
Can further clearly understand the present invention by the following specific embodiments of the invention that provide.But they are not limitation of the invention.
Embodiment:
By 1000 calculating of preparation, the composition of supplementary material and proportioning are:
Cefditoren pivoxil Cephalosporins 100g
Microcrystalline Cellulose 50g
Polyvinylpolypyrrolidone 8g
Protein sugar 20g
3% hypromellose solution is an amount of
Magnesium stearate 1g
Make 1000
Preparation method:
1. supplementary material is crossed 100 mesh sieves.
2. take by weighing hypromellose, add water and make 3% solution, standby.
3. take by weighing recipe quantity Cefditoren pivoxil Cephalosporins, microcrystalline Cellulose, protein sugar and half recipe quantity polyvinylpolypyrrolidone, mix homogeneously adds 3% hypromellose solution and makes soft material in right amount, 20 orders are granulated, 60 ℃ of forced air dryings, 24 order granulate, add residue polyvinylpolypyrrolidone and magnesium stearate, total mixing.
4. sampling, intermediate detects.
5. tabletting is packed.
6. inspection entirely, warehouse-in.
Every of this product contains Cefditoren pivoxil Cephalosporins 0.1g, the heavily about 0.18g of sheet.
Detection to preparation:
Cefditoren dispersible tablet to the present invention's preparation has carried out external dispersion, dissolution and stability test, simultaneously with listing sample Meiact
(cefditoren sheet) carries out quality comparative study, and the result shows that product of the present invention disperses, stripping is rapid, steady quality.
1, according to Chinese Pharmacopoeia, with this preparation and listing sample Meiact
(cefditoren sheet) carries out quality comparative study, relatively this product and Meiact
Dissolution rate in vitro, the result shows the dissolution rate of this product apparently higher than the cefditoren tablet, 5 minutes dissolution can reach 71.3%, sees Table I (data of this preparation are continuous three batch data averages).By data as can be known, compare with conventional tablet, the cefditoren dispersible tablet has higher disintegrate rate of dispersion and dissolution, thereby can fully be absorbed with the better antibacterial action of performance quickly.
Table I cefditoren dispersible tablet and the comparative test of cefditoren sheet dissolution rate
| Time (branch) | 5 | 10 | 15 | 20 | 30 |
| The cefditoren dispersible tablet | 713％ | 87.5％ | 99.6％ | 98.7％ | 101.5％ |
| The cefditoren sheet | 36.8％ | 57.8％ | 82.9％ | 98.3％ | 100.2％ |
2, stability test
(1) carries out accelerated test according to Chinese Pharmacopoeia, this product placed under 40 ℃, the condition of RH75% investigate 6 months, respectively at 0,1,2,3, the sampling in June detects, leading indicators such as the character before and after investigation is placed, dispersing uniformity, dissolution, related substance, content the results are shown in Table II (data of this preparation are continuous three batch data averages).The result shows that this product investigates 6 months under the accelerated test condition, and significant change does not all take place every index of examining.
Table II cefditoren dispersible tablet accelerated test is investigated the result
| Time (moon) | Character | Dispersing uniformity | Dissolution | Related | Content | |
| 0 | White tablets | Up to specification | 98.6 | 0.32 | 99.3 | |
| 1 | White tablets | Up to specification | 100.9 | 0.28 | 101.3 | |
| 2 | White tablets | Up to specification | 102.5 | 0.35 | 100.5 | |
| 3 | White tablets | Up to specification | 99.2 | 0.29 | 101.1 | |
| 6 | White tablets | Up to specification | 98.7 | 0.34 | 99.6 |
(2) carry out long term test according to Chinese Pharmacopoeia, this product placed under 25 ℃, the condition of RH60% investigate 6 months, respectively at 0,3, the sampling in June detects, leading indicators such as the character before and after investigation is placed, dispersing uniformity, dissolution, related substance, content the results are shown in Table III (data of this preparation are continuous three batch data averages).The result shows that this product investigates 6 months under the long term test condition, and significant change does not all take place every index of examining.
Table III cefditoren dispersible tablet long term test is investigated the result
| Time (moon) | Character | Dispersing uniformity | Dissolution | Related | Content | |
| 0 | White tablets | Up to specification | 98.6 | 0.32 | 100.6 | |
| 3 | White tablets | Up to specification | 101.5 | 0.36 | 102.0 | |
| 6 | White tablets | Up to specification | 99.6 | 0.38 | 99.8 |
The result of compbined test shows, dispersed cefditoren pivoxil tablet technical maturity, the constant product quality of the present invention's preparation; And disintegrate disperses soon, dissolution is high, can fully be absorbed with the better antibacterial action of performance quickly.
Usage and dosage: oral or with taking after the aqueous dispersion.Usual amounts a: 200mg, one after each meal.Suitably increase and decrease with age and symptom.
The animal pharmacokinetics comparative test research of preparation and ordinary tablet:
Get 8 of healthy rabbits, male and female are regardless of, body weight 2.0～2.4kg, taking food gave Cefditoren pivoxil Cephalosporins tablet 200mg in 2 hours, got blood 3.0ml anticoagulant heparin in 0.5,1,2,3,4,5,6,8,12,24 hour after administration, and centrifugal back is pressed preceding method and handled, calculate blood drug level, week back stomach filling gives 200mg dispersed cefditoren pivoxil tablet (grinding the back administration) at interval, record different time blood drug level data, and make serum drug level-time graph.
Different time serum drug level-time data and curve Table IV, Table V and accompanying drawing 2 as follows after two kinds of dosage forms of rabbit oral administration.Institute's image data is analyzed with 3p87 program (establishment of mathematics pharmacology committee of Chinese Pharmacological Society).The result shows that the medicine blood drug level data of two dosage forms of rabbit oral administration all meet one-compartment model.Each pharmacokinetic parameters no significant difference of ordinary tablet and dispersible tablet (P＞0.05).But ordinary tablet is low than dispersible tablet blood drug level, and peak time is postponed, and the bioavailability of two kinds of dosage forms is respectively: ordinary tablet 42.6%, dispersible tablet 56.7%.
Table IV serum drug level-time data (mgL-1)
| t(h) | The C ordinary tablet | The C dispersible tablet |
| 0.5 1 2 3 4 5 6 8 12 24 | 0.58 1.57 2.16 2.41 2.14 1.1 0.66 0.6 0.4 0.2 | 0.63 2.19 2.64 2.18 1.63 1.24 0.73 0.62 0.45 0.28 |
Two kinds of dosage form pharmacokinetic parameters of Table V Cefditoren pivoxil Cephalosporins (n=8)
| Parameter | Unit | Ordinary tablet | Dispersible tablet |
| A Ke Ka T 1/2Ka T 1/2Ke Tpeak Cmax AUC CL V | mg·mL -1 L·h -1 L·h -1 h h h mg·mL -1 mg·h·mL -1 L·h -1 L·Kg -1 | 0.53 1.53 2.92 3.52 2.91 2.12 2.41 0.55 0.31 0.27 | 0.61 1.59 2.99 3.61 2.99 2.19 2.67 0.62 0.38 0.34 |
The basically identical of the main pharmacokinetic parameter of test gained and domestic and foreign literature report, the pharmacokinetic of rabbit shows that every pharmacokinetics index of a cefditoren ester novel form and conventional tablet relatively do not have significant difference, and two kinds of dosage forms have bioequivalence.But the index Tpeak of reflection drug absorption speed, Cmax; The reflection medicine is eliminated the index T1 of speed
/ 2The index AUC of reflection medicine whole body absorbtivity
0-tDispersant is all apparently higher than conventional tablet.The drug effect of prompting dispersed cefditoren pivoxil tablet is better than ordinary tablet.
Claims (7)
1, a kind of new dispersed cefditoren pivoxil tablet is characterized in that said preparation is by principal agent---Cefditoren pivoxil Cephalosporins, add filler, and disintegrating agent and correctives mix, through granulation, forced air drying, granulate, total mixing, tabletting makes dispersed cefditoren pivoxil tablet.
2, a kind of preparation method of new dispersed cefditoren pivoxil tablet, it is characterized in that said preparation is by Cefditoren pivoxil Cephalosporins, microcrystalline Cellulose, polyvinylpolypyrrolidone, protein sugar, hypromellose solution, magnesium stearate is formed, supplementary material is crossed 100 mesh sieves, take by weighing hypromellose, add water and make 3% solution, standby, take by weighing the recipe quantity Cefditoren pivoxil Cephalosporins, microcrystalline Cellulose, protein sugar and recipe quantity polyvinylpolypyrrolidone, mix homogeneously adds 3% hypromellose solution and makes soft material in right amount, through granulating, forced air drying, granulate adds residue polyvinylpolypyrrolidone and magnesium stearate, total mixing, tabletting makes.
3, the preparation method of dispersed cefditoren pivoxil tablet according to claim 2 is characterized in that being made up of following parts by weight material: 50～150 parts of Cefditoren pivoxil Cephalosporins, 10～500 parts of microcrystalline Cellulose, 5～50 parts of polyvinylpolypyrrolidone, 5～50 parts of protein sugar, 3% hypromellose solution are an amount of, 0.5～5 part of magnesium stearate.
4, the preparation method of dispersed cefditoren pivoxil tablet according to claim 2 is characterized in that following these steps to the preparation technology of the dispersible tablet of Cefditoren pivoxil Cephalosporins finish:
1. supplementary material is crossed 100 mesh sieves;
2. take by weighing hypromellose, add water and make 3% solution, standby;
3. take by weighing recipe quantity Cefditoren pivoxil Cephalosporins, microcrystalline Cellulose, protein sugar and half recipe quantity polyvinylpolypyrrolidone, mix homogeneously adds 3% hypromellose solution and makes soft material in right amount, 20 orders are granulated, 60 ℃ of forced air dryings, 24 order granulate, add residue polyvinylpolypyrrolidone and magnesium stearate, total mixing;
4. sampling, intermediate detects;
5. tabletting is packed;
6. inspection entirely, warehouse-in.
5, dispersed cefditoren pivoxil tablet according to claim 1 is characterized in that described filler comprises microcrystalline Cellulose, starch, lactose, dextrin, mannitol, but is not limited to above-mentioned filler.
6, dispersed cefditoren pivoxil tablet according to claim 1 is characterized in that described disintegrating agent comprises polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, carboxymethyl starch sodium, pregelatinized Starch, but is not limited to above-mentioned disintegrating agent.
7, dispersed cefditoren pivoxil tablet according to claim 1 is characterized in that described correctives comprises protein sugar, stevioside, saccharin sodium, aspartame, sweet close element, flavoring orange essence, Fructus Citri Limoniae essence, but is not limited to above-mentioned correctives.
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| CN 200610050672 CN1846702A (en) | 2006-05-10 | 2006-05-10 | Dispersed cefditoren pivoxil tablet and its prepn process |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011139251A1 (en) * | 2010-05-04 | 2011-11-10 | Mahmut Bilgic | Pharmaceutical compositions comprising cefditoren pivoxil |
| CN102716098A (en) * | 2012-06-29 | 2012-10-10 | 海南美大制药有限公司 | Cefditoren pivoxil liposome solid preparation |
| CN112190539A (en) * | 2020-11-10 | 2021-01-08 | 深圳立健药业有限公司 | Cefditoren pivoxil composition and application thereof |
| CN114306246A (en) * | 2020-09-29 | 2022-04-12 | 北京济美堂医药研究有限公司 | Preparation method of cefditoren pivoxil granules |
-
2006
- 2006-05-10 CN CN 200610050672 patent/CN1846702A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011139251A1 (en) * | 2010-05-04 | 2011-11-10 | Mahmut Bilgic | Pharmaceutical compositions comprising cefditoren pivoxil |
| CN102716098A (en) * | 2012-06-29 | 2012-10-10 | 海南美大制药有限公司 | Cefditoren pivoxil liposome solid preparation |
| CN102716098B (en) * | 2012-06-29 | 2014-01-15 | 海南美大制药有限公司 | Cefditoren pivoxil liposome solid preparation |
| CN114306246A (en) * | 2020-09-29 | 2022-04-12 | 北京济美堂医药研究有限公司 | Preparation method of cefditoren pivoxil granules |
| CN112190539A (en) * | 2020-11-10 | 2021-01-08 | 深圳立健药业有限公司 | Cefditoren pivoxil composition and application thereof |
| CN112190539B (en) * | 2020-11-10 | 2021-11-02 | 深圳立健药业有限公司 | Cefditoren pivoxil composition and application thereof |
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Open date: 20061018 |