CN101744782B - Tablet containing faropenem sodium - Google Patents
Tablet containing faropenem sodium Download PDFInfo
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- CN101744782B CN101744782B CN2010101091391A CN201010109139A CN101744782B CN 101744782 B CN101744782 B CN 101744782B CN 2010101091391 A CN2010101091391 A CN 2010101091391A CN 201010109139 A CN201010109139 A CN 201010109139A CN 101744782 B CN101744782 B CN 101744782B
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Abstract
The invention relates to a tablet containing faropenem sodium, belonging to the field of pharmaceutical preparation. The faropenem sodium tablet of the invention comprises 20-50 parts of faropenem sodium, 20-25 parts of disintegrant, 2-10 parts of 95% ethanol solution containing 5% of polyvinylpyrrolidone, 20-30 parts of filler and 0.5-2 parts of lubricant. The faropenem sodium tablet of the invention has the advantages of fast disintegration speed and stable properties in high-temperature and high-humidity environment, can effectively improve the effect-taking concentration and bioavailability of faropenem, and is very suitable for old people and children with dysphagia to take.
Description
Technical field
The present invention relates to a kind of tablet that contains Faropenem sodium, belong to field of pharmaceutical preparations.
Background technology
Faropenem (Faropenem) is an atypia beta-lactam antibiotic, belongs to the derivant of penems.
Carbapenems and penems two big compounds have attracted the great interest of people, and penems more has unique advantage, and existing five carbapenem derivatives are among exploitation, and faropenem is one of them.Except that more weak to the inhibition bacillus pyocyaneus, its has a broad antifungal spectrum, effective especially to anaerobe surpasses carbapenem antibiotic.It demonstrates broad-spectrum antibacterial activity to aerobic and anaerobic gram positive bacteria, gram-negative bacteria, and particularly the activity to anaerobe such as gram positive bacterias such as drug-fast staphylococcus, enterococcus and bacteroids all is superior to the existing oral antimicrobial drug.Faropenem and penicillin-binding protein have good affinity and good beta-lactam enzyme stability, and less generation drug resistance is mainly used in respiratory system infection, urinary system infection, genital system infection and biliary tract infection etc. due to the sensitive bacterial.But in the Faropenem sodium stability test, sample was 40 ℃ and 60 ℃ of condition held 5 days and 10 days, and impurity all has more a large amount of increases, and the prompting sample is unstable to temperature, answers cryopreservation.Beta-Lactam antibiotic is responsive to moisture usually, and its main degradation pathway is that the beta-lactam nucleus in the molecule is degraded by the attack open loop of hydrone, and response speed depends on the water content in the system.At a lower temperature; The thermal decomposition speed of cephalosporin increases (Zhao Xia with the increase of water content in the sample; Hu Changqin, Jin Shaohong. the structural identification of the research of Faropenem sodium Degradation Characteristics and main thermal degradation product. Chinese antibiosis rope magazine .2005,6 (30): 341～343).
CN1616080 (open day a 2005.05.18) discloses a kind of faropenem pharmaceutical composition that contains glutathion, and said composition contains pharmaceutically acceptable salt of faropenem or its pharmaceutically acceptable salt or hydrate and glutathion or its.
CN101011394 (open day 2006.11.28) discloses quick-acting injections of a kind of Faropenem sodium and long-acting injection.
Summary of the invention
In order to solve the deficiency of prior art; The invention provides a kind of tablet of Faropenem sodium, overcome Faropenem sodium conventional tablet flavour of a drug suffering swallowing, shortcoming such as poor stability under sour environment and the thermal environment; Taking convenience; Significantly reduce the side reaction of medication, improved the compliance of patient's medication, also can reach the purpose of quick acting simultaneously.
A kind of tablet that contains Faropenem sodium provided by the invention, it is made up of the component of following weight portion:
Faropenem sodium 20-50 part
20～25 parts of disintegrating agents
2～10 parts of the alcoholic solution of 5% polyvinylpyrrolidone 95%
20～30 parts of filleies
0.5～2 part of lubricant
In the prescription of above-mentioned faropenem sodium tablet, described disintegrating agent is selected from low-substituted hydroxypropyl cellulose (L-HPC) or/and crospolyvinylpyrrolidone (PVPP).
In the prescription of above-mentioned faropenem sodium tablet, described filler is selected from one or more in microcrystalline Cellulose, micropowder silica gel and the starch.
In the prescription of above-mentioned faropenem sodium tablet, described lubricant is selected from one or more in micropowder silica gel, magnesium stearate and the Pulvis Talci.
The faropenem sodium tablet can also contain correctives, and said correctives is one or more in stevioside, saccharin sodium and the aspartame.
Dispersing uniformity and dissolution in vitro experiment through effect embodiment 7 Faropenem sodium sheets can be found out; The faropenem sodium tablet dissolution of embodiment of the invention preparation is superior to the Faropenem sodium ordinary tablet of prior art report; Especially the external dissolution rate of tablet of embodiment 3,5 preparations is fast; Stripping difference is little, accumulates stripping quantity in 50 seconds near 100%, almost all strippings; And the reference substance stripping is slow, and dissolution difference is big between sheet, and 5min accumulation stripping quantity is only about 90%.
Therefore, in preferred embodiment of the present invention, said faropenem sodium tablet is made up of the component of following weight portion:
44.1 parts of Faropenem sodiums (principal agent)
25.7 parts of microcrystalline Cellulose (filler)
4.3 parts of micropowder silica gels (filler)
20 parts of crospolyvinylpyrrolidone (disintegrating agent)
1.4 parts of aspartames (correctives)
The 5%PVPk3095% alcoholic solution is an amount of
0.8 part of magnesium stearate (lubricant)
In another preferred embodiment of the present invention, said faropenem sodium tablet is made up of the component of following weight portion:
44.1 parts of Faropenem sodiums (principal agent)
25.7 parts of starch (filler)
4.3 parts of micropowder silica gels (filler)
12.8 parts of crospolyvinylpyrrolidone (disintegrating agent)
7.1 parts of low-substituted hydroxypropyl celluloses (disintegrating agent)
1.4 parts of aspartames (correctives)
The 5%PVPk3095% alcoholic solution is an amount of
0.8 part of magnesium stearate (lubricant)
The present invention compared with prior art has following obvious improvement:
Faropenem sodium tablet by method for preparing of the present invention obtains is compared with commercially available Faropenem sodium ordinary tablet, and it has improved the dissolution in vitro of medicine greatly.Can find out by table 1; Each faropenem sodium tablet of the embodiment of the invention and reference substance disintegration time and dissolution are all stable; Meet its formulation characteristic; Especially dissolution has all reached more than 96% in the tablet of processing with reference to embodiment 3 and embodiment 5,1min, and dissolution rate obviously is superior to the tablet that other embodiment process.Also almost completely stripping in 150s of the tablet that other embodiment processes.Faropenem sodium tablet comparison of the present invention significantly reduces according to article disintegration, the more ingredient of internal energy stripping of short time, and it is faster in human body, to show as onset, and drug level is higher, and the old man and the child that are more suitable for dysphagia take.
In addition; Can find out that by table 2 along with the increase of storage time, the disintegration time of faropenem sodium tablet of the present invention and reference substance all has prolongation in various degree; But the dissolution substantially constant of faropenem sodium tablet of the present invention, and reference substance dissolution at high temperature obviously reduces.It is constant that the content of faropenem sodium tablet of the present invention also keeps, and the sample that the reference substance tablet was stored 0 day under hot environment relatively decreases, and points out faropenem sodium tablet heat stability of the present invention more stable than reference substance.Faropenem sodium tablet of the present invention content and dissolution under high humidity environment increase no change with storage time; Reference substance tablet content and dissolution under high humidity environment all decrease, and prompting method faropenem tablet is more stable than Faropenem sodium conventional tablet under high humidity environment.Faropenem sodium tablet color color and luster homogeneous in addition, the storage no change.Faropenem sodium conventional tablet storage after ten days color become light yellow by initial off-white color.
The specific embodiment
This part embodiment comprises embodiment 1-8, and faropenem sodium tablet provided by the invention is not limited only to the embodiment of this part.
Embodiment 1 faropenem sodium tablet
Faropenem sodium (principal agent) 123.5g
Microcrystalline Cellulose (filler) 44g
Micropowder silica gel (filler) 12g
Crospolyvinylpyrrolidone (disintegrating agent) 64g
Low-substituted hydroxypropyl cellulose (disintegrating agent) 20g
Aspartame 4g
The 5%PVPk3095% alcoholic solution is an amount of
Magnesium stearate (lubricant) 0.8%
Make 1000 altogether, the every heavy 0.28g of sheet, principal agent is counted 0.10g with faropenem.
Preparation technology: crude drug was pulverized 100 mesh sieves; Remaining adjuvant was pulverized 80 mesh sieves; Accurately take by weighing the supplementary material of recipe quantity, mix homogeneously, the 5%PVPk3095% alcoholic solution is granulated, 18 mesh sieve granulate, 40 ℃ of dryings.The magnesium stearate that adds recipe quantity, mix homogeneously is crossed 18 mesh sieves, measures the granule drug content, confirms that sheet is heavy, and tabletting promptly gets.The gained tablet is limited to 48s when disperseing.
Embodiment 2 faropenem sodium tablets
Faropenem sodium (principal agent) 123.5g
Microcrystalline Cellulose (filler) 72g
Micropowder silica gel (filler) 12g
Crospolyvinylpyrrolidone (disintegrating agent) 36g
Low-substituted hydroxypropyl cellulose (disintegrating agent) 20g
Aspartame 4g
The 5%PVPk3095% alcoholic solution is an amount of
Magnesium stearate (lubricant) 0.8%
Make 1000 altogether, the every heavy 0.28g of sheet, principal agent is counted 0.10g with faropenem.
Preparation technology: crude drug was pulverized 100 mesh sieves; Remaining adjuvant was pulverized 80 mesh sieves; Accurately take by weighing the supplementary material of recipe quantity, mix homogeneously, the 5%PVPk3095% alcoholic solution is granulated, 18 mesh sieve granulate, 40 ℃ of dryings.The magnesium stearate that adds recipe quantity, mix homogeneously is crossed 18 mesh sieves, measures the granule drug content, confirms that sheet is heavy, and tabletting promptly gets.Gained tablet jitter time is 84s.
Embodiment 3 faropenem sodium tablets
Faropenem sodium (principal agent) 123.5g
Microcrystalline Cellulose (filler) 60g
Micropowder silica gel (filler) 10g
Crospolyvinylpyrrolidone (disintegrating agent) 60g
Low-substituted hydroxypropyl cellulose (disintegrating agent) 10g
Aspartame 4g
The 5%PVPk3095% alcoholic solution is an amount of
Magnesium stearate (lubricant) 0.8%
Make 1000 altogether, the every heavy 0.28g of sheet, principal agent is counted 0.10g with faropenem.
Preparation technology: crude drug was pulverized 100 mesh sieves; Remaining adjuvant was pulverized 80 mesh sieves; Accurately take by weighing the supplementary material of recipe quantity, mix homogeneously, the 5%PVPk3095% alcoholic solution is granulated, 18 mesh sieve granulate, 40 ℃ of dryings.The magnesium stearate that adds recipe quantity, mix homogeneously is crossed 18 mesh sieves, measures the granule drug content, confirms that sheet is heavy, and tabletting promptly gets.Gained tablet jitter time is 72s.
Embodiment 4 faropenem sodium tablets
Faropenem sodium (principal agent) 123.5g
Starch (filler) 72g
Micropowder silica gel (filler) 12g
Crospolyvinylpyrrolidone (disintegrating agent) 36g
Low-substituted hydroxypropyl cellulose (disintegrating agent) 20g
Aspartame 4g
The 5%PVPk3095% alcoholic solution is an amount of
Magnesium stearate (lubricant) 0.8%
Make 1000 altogether, the every heavy 0.28g of sheet, principal agent is counted 0.10g with faropenem.
Preparation technology: crude drug was pulverized 100 mesh sieves; Remaining adjuvant was pulverized 80 mesh sieves; Accurately take by weighing the supplementary material of recipe quantity, mix homogeneously, the 5%PVPk3095% alcoholic solution is granulated, 18 mesh sieve granulate, 40 ℃ of dryings.The magnesium stearate that adds recipe quantity, mix homogeneously is crossed 18 mesh sieves, measures the granule drug content, confirms that sheet is heavy, and tabletting promptly gets.Gained tablet jitter time is 108s.
Embodiment 5 faropenem sodium tablets
Faropenem sodium (principal agent) 123.5g
Microcrystalline Cellulose (filler) 72g
Micropowder silica gel (filler) 12g
Crospolyvinylpyrrolidone (disintegrating agent) 56g
Aspartame 4g
The 5%PVPk3095% alcoholic solution is an amount of
Magnesium stearate (lubricant) 0.8%
Make 1000 altogether, the every heavy 0.28g of sheet, principal agent is counted 0.10g with faropenem.
Preparation technology: crude drug was pulverized 100 mesh sieves; Remaining adjuvant was pulverized 80 mesh sieves; Accurately take by weighing the supplementary material of recipe quantity, mix homogeneously, the 5%PVPk3095% alcoholic solution is granulated, 18 mesh sieve granulate, 40 ℃ of dryings.The magnesium stearate that adds recipe quantity, mix homogeneously is crossed 18 mesh sieves, measures the granule drug content, confirms that sheet is heavy, and tabletting promptly gets.Gained tablet jitter time is 126s.
Embodiment 6 faropenem sodium tablets
Faropenem sodium (principal agent) 123.5g
Microcrystalline Cellulose (filler) 72g
Micropowder silica gel (filler) 12g
Low-substituted hydroxypropyl cellulose (disintegrating agent) 56g
Aspartame 4g
The 5%PVPk3095% alcoholic solution is an amount of
Magnesium stearate (lubricant) 0.8%
Make 1000 altogether, the every heavy 0.28g of sheet, principal agent is counted 0.10g with faropenem.
Preparation technology: crude drug was pulverized 100 mesh sieves; Remaining adjuvant was pulverized 80 mesh sieves; Accurately take by weighing the supplementary material of recipe quantity, mix homogeneously, the 5%PVPk3095% alcoholic solution is granulated, 18 mesh sieve granulate, 40 ℃ of dryings.The magnesium stearate that adds recipe quantity, mix homogeneously is crossed 18 mesh sieves, measures the granule drug content, confirms that sheet is heavy, and tabletting promptly gets.Gained tablet jitter time is 132s.
Embodiment 7 faropenem sodium tablet dispersing uniformities and dissolution in vitro are measured
1. faropenem sodium tablet dispersing uniformity inspection
Its dispersing uniformity experimental technique of faropenem sodium tablet (embodiment 1-6) is following: gets 2 of these article, puts jolting in the 100ml water, and in 20 ± 1 ℃ of water, all disintegrates and in 3 minutes through No. 2 sieves.
2. faropenem sodium tablet dissolution in vitro detects
Reference substance: Faropenem sodium sheet, Jiangsu Zhengda Tianqing Drug Industry Co., Ltd, 0.15g/ sheet; Product batch number 061109 faropenem sodium tablet (embodiment 1-6) and reference substance dissolution experimental technique are following: get these article according to dissolution method, 500ml is a solvent with hydrochloric acid solution (9 → 1000), and rotating speed is that per minute 50 changes; Operation in accordance with the law in the time of 30 minutes, is got solution 10ml; Filter, get 3ml and put in the 100ml measuring bottle and use with a kind of solvent dilution to scale.HPLC measures the concentration of Faropenem sodium in the solution, calculates the tablet dissolution.Limit is 80% of the sign degree, should be up to specification.Dispersibility and the dissolution of measuring tablet among each embodiment are as shown in table 1.
Each embodiment tablet dispersibility of table 1 and dissolution assay
Can find out by table 1; Each faropenem sodium tablet of the embodiment of the invention and reference substance disintegration time and dissolution are all stable; Meet its formulation characteristic; Especially dissolution has all reached more than 96% in the tablet of processing with reference to embodiment 3 and embodiment 5,1min, and dissolution rate obviously is superior to the tablet that other embodiment process.Also almost completely stripping in 150s of the tablet that other embodiment process.Faropenem sodium tablet comparison of the present invention significantly reduces according to article disintegration, the more ingredient of internal energy stripping of short time, and it is faster in human body, to show as onset, and drug level is higher, and the old man and the child that are more suitable for dysphagia take.
The study on the stability of embodiment 8 faropenem sodium tablets
We have carried out factors influencing to outward appearance, dissolution, content and the disintegration time of product that embodiment does.
(1) hot test: get embodiment of the invention 1-6 sample and reference substance (Faropenem sodium sheet; Jiangsu Zhengda Tianqing Drug Industry Co., Ltd; 0.15g/ sheet, product batch number 061109) be tiled in right amount in the culture dish, place 60 ℃ calorstat to place 10 days; During this 0th, 5,10 day, taking sample determination respectively.Measure the result and see table 2.
(2) high wet test: sample thief is tiled in the culture dish in right amount, in the condition held of 25 ℃ of relative humidity RH90% ± 5% 10 days, and with during this 0th, 5,10 day, the outward appearance of taking sample determination sample, dissolution, content and disintegration time.Measure the result and see table 2.
(3) strong illumination test: sample thief is tiled in the culture dish in right amount, places the light cupboard the condition illumination of 4500Lx ± 500Lx 10 days, and during this 0th, 5,10 day, the outward appearance of taking sample determination sample, dissolution, content and disintegration time.The result sees table 2.
Each embodiment tablet of table 2 is hot and humid and high light is stable down
Along with the increase of storage time, the disintegration time of faropenem sodium tablet of the present invention and reference substance all has prolongation in various degree, but the dissolution substantially constant of faropenem sodium tablet of the present invention, and reference substance dissolution at high temperature obviously reduces.It is constant that the content of faropenem sodium tablet of the present invention also keeps, and the sample that the reference substance tablet was stored 0 day under hot environment relatively decreases, and points out faropenem sodium tablet heat stability of the present invention more stable than reference substance.Faropenem sodium tablet of the present invention content and dissolution under high humidity environment increase no change with storage time; Reference substance tablet content and dissolution under high humidity environment all decrease, and prompting method faropenem tablet is more stable than Faropenem sodium conventional tablet under high humidity environment.Faropenem sodium tablet color color and luster homogeneous in addition, the storage no change.Faropenem conventional tablet storage after ten days color become light yellow by initial off-white color.
Claims (1)
1. tablet that contains Faropenem sodium is characterized in that it is made up of the component of following weight portion:
50 parts of Faropenem sodiums
20～25 parts of disintegrating agents
2～10 parts of the alcoholic solution of 5% polyvinylpyrrolidone 95%
20～30 parts of filleies
0.5～2 part of lubricant
Described disintegrating agent is selected from low-substituted hydroxypropyl cellulose or/and crospolyvinylpyrrolidone; Described filler is selected from one or more in microcrystalline Cellulose, micropowder silica gel and the starch; Described lubricant is a magnesium stearate.
2, a kind of tablet that contains Faropenem sodium is characterized in that being made up of the component of following weight portion:
44.1 parts of Faropenem sodiums
25.7 parts of microcrystalline Cellulose
4.3 parts of micropowder silica gels
20 parts of crospolyvinylpyrrolidone
1.4 parts of aspartames
5%PVP
K3095% alcoholic solution is an amount of
0.8 part of magnesium stearate.
3, a kind of tablet that contains Faropenem sodium is characterized in that being made up of the component of following weight portion:
44.1 parts of Faropenem sodiums
25.7 parts of starch
4.3 parts of micropowder silica gels
12.8 parts of crospolyvinylpyrrolidone
7.1 parts of low-substituted hydroxypropyl celluloses
1.4 parts of aspartames
5%PVP
K3095% alcoholic solution is an amount of
0.8 part of magnesium stearate.
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| CN2010101091391A CN101744782B (en) | 2010-01-24 | 2010-01-24 | Tablet containing faropenem sodium |
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| CN101744782B true CN101744782B (en) | 2012-03-21 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104027310A (en) * | 2013-12-26 | 2014-09-10 | 青岛大学 | Faropenem sodium granules and preparing method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1336827A (en) * | 1999-10-12 | 2002-02-20 | 三得利株式会社 | Medicinal compositions for oral use |
| CN1616080A (en) * | 2004-09-16 | 2005-05-18 | 沈阳中海生物技术开发有限公司 | Faluopeinan medicine composition containing glutathione |
| CN1843354A (en) * | 2006-05-10 | 2006-10-11 | 鲁南制药集团股份有限公司 | Injectable pharmaceutical composition containing faropenem |
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2010
- 2010-01-24 CN CN2010101091391A patent/CN101744782B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1336827A (en) * | 1999-10-12 | 2002-02-20 | 三得利株式会社 | Medicinal compositions for oral use |
| CN1616080A (en) * | 2004-09-16 | 2005-05-18 | 沈阳中海生物技术开发有限公司 | Faluopeinan medicine composition containing glutathione |
| CN1843354A (en) * | 2006-05-10 | 2006-10-11 | 鲁南制药集团股份有限公司 | Injectable pharmaceutical composition containing faropenem |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104027310A (en) * | 2013-12-26 | 2014-09-10 | 青岛大学 | Faropenem sodium granules and preparing method thereof |
| CN104027310B (en) * | 2013-12-26 | 2016-02-03 | 青岛大学 | A kind of faropenem sodium granules and preparation method thereof |
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| CN101744782A (en) | 2010-06-23 |
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