CN1203787A - Ketoprofen slow-releasing tablet and its preparing method - Google Patents
Ketoprofen slow-releasing tablet and its preparing method Download PDFInfo
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- CN1203787A CN1203787A CN 97112580 CN97112580A CN1203787A CN 1203787 A CN1203787 A CN 1203787A CN 97112580 CN97112580 CN 97112580 CN 97112580 A CN97112580 A CN 97112580A CN 1203787 A CN1203787 A CN 1203787A
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- ketoprofen
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Abstract
The present invention relates to a non-steroidal antiinflammatory ketoprofen slow release tablet. Its main ingredients are ketoprofen, slow release skeletal substrate and adhesive. The slow release skeletal substrate is cellulose derivative and vinyl polymer. Said slow release material is low in cost, easily available, and can implement industrial large-scale production.
Description
The present invention relates to a kind of new drug formulation preparation of nonsteroidal anti-inflammatory drug preparation category, particularly a kind of ketoprofen slow-release sheet and process thereof.
Slow releasing tablet is a rising high tech novel form in recent years, uses the pharmacokinetics principle, makes with special adjuvant and technology.Medicine is arrived behind the gastrointestinal by slowly discharging in the dosage form for absorption, low " peak valley " phenomenon when high when therefore having avoided the common blood drug level of ordinary preparation.Thereby can not only stably keep the necessary blood drug level of treatment the long period, and its blood drug level is far away with the least concentration distance that toxic and side effects takes place, and has guaranteed the safety and effectiveness of medication, and easy to use.
Ketoprofen (Ketoprofen) chemical name is Alpha-Methyl-3-benzoyl-phenylacetic acid; be that the eighties is widely used in clinical nonsteroidal anti-inflammatory drug both at home and abroad; in many nonsteroidal anti-inflammatory drugs; ketoprofen is many with its clinical use research; toxic and side effects is little; being widely used and being recorded by pharmacopeia, is one of choice drug as the various rheumatic arthritis of treatment, rheumatoid arthritis, ankylosing spondylitis, acute gout and antipyretic-antalgic.But the weak point of ketoprofen is half-life short (about 2h), and patient need frequently take medicine (every day three~four times).In recent years ketoprofen is made slow releasing capsule abroad, only need sooner or later respectively to take medicine once, can make the patient obtain the ideal treatment blood drug level protection of 24h, improve drug effect and tolerance, obviously reduce gastrointestinal side effect.But China does not still have the slow release formulation of this medicine.
The external synthesized polymer material that adopts is done slow releasing capsule, and this type of material resources is in short supply, cost an arm and a leg, and preparation piller coating and capsule form needs special installation, and technology difficulty is big, in China's suitability for industrialized production difficulty.
Purpose of the present invention is exactly under the prerequisite that guarantees the product slow releasing function, adopts domestic resourceful sustained-release matrix substrate, preferably is fit to the technology of national conditions, forms low-cost, large-tonnage industrial advantages, fills up domestic this blank.
The present invention realizes with following technical scheme:
Develop ketoprofen slow-release sheet and process thereof a kind of nonsteroidal anti-inflammatory drug preparation category, that comprise formations such as principal agent, sustained-release matrix substrate and adjuvant, it is characterized in that its main component is principal agent, sustained-release matrix substrate and necessary adjuvant component, wherein:
1. principal agent is a non-steroidal anti-inflammatory medicine ketoprofen,
2. sustained-release matrix substrate can be cellulose derivative and polyvinyl,
3. the necessary adjuvant component in the adjuvant is a binding agent,
Above-mentioned ketoprofen slow-release sheet and process thereof, described sustained-release matrix substrate can be cellulose derivative and polyvinyl, is meant that sustained-release matrix substrate can be from hydroxypropyl emthylcellulose with slow release characteristic, polyvinylpyrrolidone, polyvinyl alcohol, hydroxyethyl-cellulose, hydroxypropyl cellulose or by selecting its mixture of forming.
Above-mentioned ketoprofen slow-release sheet and process thereof, binding agent in the described necessary adjuvant component can be from hydroxypropyl emthylcellulose, polyvinylpyrrolidone, methylcellulose, ethyl cellulose, low-substituted hydroxypropyl cellulose, starch, sucrose, dextrin and lactose with adhesion characteristic or by selecting its one group of binding agent forming.
Above-mentioned ketoprofen slow-release sheet and process thereof, the ratio between described each main component is:
Principal agent: sustained-release matrix substrate=1: 0.2~4.
The process of slow releasing tablet of the present invention is the preparation method of conventional tablet.Facts have proved that compare with background technology, the present invention has following advantage:
1. sustained-release matrix substrate is based on our country, aboundresources, inexpensive;
2. process of the present invention is the preparation method of conventional tablet, need not to increase extras and investment, the energy mass industrialized production;
3. the product drug effect is long, side effect is little;
Therefore the present invention has very big advantage and potentiality, has the very strong market competitiveness.
The present invention is further elaborated below in conjunction with drawings and Examples:
Fig. 1 is the ketoprofen sheet stripping curve of conventional formulation;
Fig. 2 is a product ketoprofen slow-release sheet release profiles of the present invention; Vertical coordinate is stripping (release) degree, and unit is %, and abscissa is the time, and unit is hour.
1000 of [embodiment one] preparation ketoprofen slow-release sheets,
Its prescription is:
Ketoprofen 75.0g
Hydroxypropyl emthylcellulose 15.0g
Lactose 45.0g
Dextrin 35.0g
HPMC solution is an amount of
Magnesium stearate 0.5%
Preparation technology: be the preparation technology of conventional tablet.Other adjuvant such as diluent, lubricant etc. with principal agent, sustained-release matrix substrate and necessary adjuvant component and convention amount through pulverizing, mixing, granulation, tabletting, packing, make the slow releasing tablet that meets the pharmaceutical production code requirement.
Detect other inspection item under the tablet item of its drug content, uniformity of dosage units, release and national regulation, all conformance with standard regulation through drug inspection department.
Following implementation column technological operation, result and quality situation are all with embodiment one.
1000 of [embodiment two] preparation ketoprofen slow-release sheets, its prescription is:
Ketoprofen 75.0g
Hydroxypropyl emthylcellulose 30.0g
Microcrystalline Cellulose 30.0g
PVP solution is an amount of
Magnesium stearate 0.5%[embodiment three] prepare 1000 of ketoprofen slow-release sheets, its prescription is:
Ketoprofen 75.0g
Hydroxypropyl emthylcellulose 45.0g
Hydroxyethyl-cellulose 10.0g
Lactose 15.0g
Starch 20.0g
Ethyl cellulose solution is an amount of
Magnesium stearate 0.5%[embodiment four] prepare 1000 of ketoprofen slow-release sheets, its prescription is:
Ketoprofen 75.0g
Hydroxypropyl emthylcellulose 10.0g
Low-substituted hydroxypropyl cellulose 60.0g
Starch 20.0g
Ethyl cellulose solution is an amount of
Claims (4)
1. a nonsteroidal anti-inflammatory drug preparation category comprises ketoprofen slow-release sheet and process thereof that principal agent, sustained-release matrix substrate and adjuvant etc. constitute, it is characterized in that its main component is principal agent, sustained-release matrix substrate and necessary adjuvant component, wherein:
1.1. principal agent is a non-steroidal anti-inflammatory medicine ketoprofen,
1.2. sustained-release matrix substrate can be cellulose derivative and polyvinyl,
1.3. the necessary adjuvant component in the adjuvant is a binding agent,
2. according to described ketoprofen slow-release sheet of claim 1 and process thereof, the described sustained-release matrix substrate of its qualifying part can be cellulose derivative and polyvinyl, is meant that sustained-release matrix substrate can be from hydroxypropyl emthylcellulose with slow release characteristic, polyvinylpyrrolidone, polyvinyl alcohol, hydroxyethyl-cellulose, hydroxypropyl cellulose or by selecting its mixture of forming.
3. according to described ketoprofen slow-release sheet of claim 1 and process thereof, its qualifying part is that the binding agent in the described necessary adjuvant component can be from hydroxypropyl emthylcellulose, polyvinylpyrrolidone, methylcellulose, ethyl cellulose, low-substituted hydroxypropyl cellulose, starch, sucrose, dextrin and lactose with adhesion characteristic or by selecting its one group of binding agent forming.
4. according to described ketoprofen slow-release sheet of claim 1 and process thereof, its qualifying part is that the ratio between described each main component is:
Principal agent: sustained-release matrix substrate=1: 0.2~4.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 97112580 CN1203787A (en) | 1997-06-27 | 1997-06-27 | Ketoprofen slow-releasing tablet and its preparing method |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 97112580 CN1203787A (en) | 1997-06-27 | 1997-06-27 | Ketoprofen slow-releasing tablet and its preparing method |
Publications (1)
Publication Number | Publication Date |
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CN1203787A true CN1203787A (en) | 1999-01-06 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN 97112580 Pending CN1203787A (en) | 1997-06-27 | 1997-06-27 | Ketoprofen slow-releasing tablet and its preparing method |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102000032A (en) * | 2010-11-23 | 2011-04-06 | 四川奇力制药有限公司 | Method for preparing ketoprofen slow release preparation |
CN102008462A (en) * | 2010-11-23 | 2011-04-13 | 四川奇力制药有限公司 | Ketoprofen slow release preparation |
CN106924205A (en) * | 2015-12-29 | 2017-07-07 | 北京阜康仁生物制药科技有限公司 | A kind of sustained release preparation containing Baricitinib |
-
1997
- 1997-06-27 CN CN 97112580 patent/CN1203787A/en active Pending
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102000032A (en) * | 2010-11-23 | 2011-04-06 | 四川奇力制药有限公司 | Method for preparing ketoprofen slow release preparation |
CN102008462A (en) * | 2010-11-23 | 2011-04-13 | 四川奇力制药有限公司 | Ketoprofen slow release preparation |
CN102000032B (en) * | 2010-11-23 | 2012-10-03 | 四川奇力制药有限公司 | Method for preparing ketoprofen slow release preparation |
CN106924205A (en) * | 2015-12-29 | 2017-07-07 | 北京阜康仁生物制药科技有限公司 | A kind of sustained release preparation containing Baricitinib |
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