CN1548044A - Fumaric acid-ketotifen dispersion tablet and its prepn process - Google Patents
Fumaric acid-ketotifen dispersion tablet and its prepn process Download PDFInfo
- Publication number
- CN1548044A CN1548044A CNA031287883A CN03128788A CN1548044A CN 1548044 A CN1548044 A CN 1548044A CN A031287883 A CNA031287883 A CN A031287883A CN 03128788 A CN03128788 A CN 03128788A CN 1548044 A CN1548044 A CN 1548044A
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- China
- Prior art keywords
- ketotifen
- ketotifen fumarate
- fumaric acid
- stevioside
- starch
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention is fumaric acid-ketotifen dispersion tablet and its preparation process. The fumaric acid-ketotifen dispersion tablet is one kind of chemical preparation used in the treatment of bronchial asthma and allergic rhinitis and may be used also in treating various allergic dermatitis, eczema, etc. The fumaric acid-ketotifen dispersion tablet is prepared with fumaric acid-ketotifen, avicel, lactose, starch, stevioside, talcum powder, magnesium stearate and ethanol. It has fast effect and high bioavailability.
Description
The present invention relates to a kind of treatment that is mainly used in bronchial asthma and allergic rhinitis, also can be used for multiple allergy dermatitis, the chemical drugs of diseases such as eczema.Particularly ketotifen fumarate dispersible tablet and preparation technology thereof.It is characterized in that with the ketotifen fumarate being raw material, a kind of chemical medicine preparation of making through scientific technology.
Ketotifen fumarate is a second filial generation histamine H
1Receptor antagonist.Has stronger histamine H
1The effect that receptor antagonism and inhibition anaphylaxis medium discharge, the oral drugs of a kind of novel prophylactic treatment bronchial asthma of this strain.Ketotifen fumarate is used for rhinitis and treatment of asthma in listing in 1979, in Europe, and the Asia, Australia etc. use in many areas.China's pharmacopeia version in 2000 is recorded its tablet, and disintegration time is long, and onset is slower, and bioavailability is lower.
Purpose of the present invention: in order to make the quick disintegrate of tablet, absorb rapidly, dissolution rate is fast, improves bioavailability, and we have adopted brand-new technology, are made into dispersible tablet.In addition,, Qian Jiashui can taken, molten immediately loosing and taking for convenient for children uses.According to the regulation of two appendix IA of Chinese Pharmacopoeia version in 2000, the dispersible tablet sucking that can keep in the mouth, we can suck its flavoring, make its taking convenience, and the better effect of performance in clinical practice is in the hope of obtaining better social benefit.
The present invention is achieved in that to select ketotifen fumarate 1.38g, microcrystalline Cellulose 29g, lactose 30g, starch 9g, L-hydroxypropyl cellulose 10g, stevioside 0.4g, Pulvis Talci 1.6g, magnesium stearate 0.4g, 50% ethanol for use an amount of.(1) the raw material adjuvant being crossed 100 mesh sieves respectively handles.(2) ketotifen fumarate, stevioside are mixed by the equivalent incremental method with starch, behind the mix homogeneously that sieves, with the abundant mixing of other adjuvants.(3) be wetting agent with 50% ethanol, add in the mixture, make suitable soft material.(4) granulate with 24 order nylon mesh.(5) wet grain spreads out in the dish, is controlled at 50 ℃ of dryings.(6) dried granule adds Pulvis Talci, magnesium stearate mixing.(7) tabletting gets 1000, packing, promptly.
Advantage of the present invention: because the present invention is dispersible tablet, carry, taking convenience, can be oral or suck clothes.Each 1, every day 2 times.Identical with former ketotifen fumarate sheet dose on the one.In addition,, make it also can pass through No. 2 sieve with interior disintegrate at 3 minutes owing to added microcrystalline Cellulose, L-hydroxypropyl cellulose, rapid-action, the bioavailability height; Add lactose, stevioside, made its flavoring, made things convenient for child's use.
Accompanying drawing: be the technological process that proposes according to the present invention.
Embodiment: select for use ketotifen fumarate 1.38g, microcrystalline Cellulose 29g, lactose 30g, starch 9g, L-hydroxypropyl cellulose 10g, stevioside 0.4g, Pulvis Talci 1.6g, magnesium stearate 0.4g, 50% ethanol an amount of.(1) the raw material adjuvant being crossed 100 mesh sieves respectively handles.(2) ketotifen fumarate, stevioside are mixed by the equivalent incremental method with starch, behind the mix homogeneously that sieves, with the abundant mixing of other adjuvants.(3) be wetting agent with 50% ethanol, add in the mixture, make suitable soft material.(4) granulate with 24 order nylon mesh.(5) wet grain spreads out in the dish, is controlled at 50 ℃ of dryings.(6) dried granule adds Pulvis Talci, magnesium stearate mixing.(7) tabletting gets 1000, and packing promptly gets the ketotifen fumarate dispersible tablet.
Claims (2)
1, ketotifen fumarate dispersible tablet and preparation technology thereof is characterized in that: select for use ketotifen fumarate 1.38g, microcrystalline Cellulose 29g, lactose 30g, starch 9g, L-hydroxypropyl cellulose 10g, stevioside 0.4g, Pulvis Talci 1.6g, magnesium stearate 0.4g, 50% ethanol an amount of.Granulate, dry, tabletting, be used for the treatment of bronchial asthma and allergic rhinitis, also can be used for multiple allergy dermatitis, diseases such as eczema.
2,, it is characterized in that (1) is with the 100 mesh sieves processing excessively respectively of raw material adjuvant according to the particulate preparation technology of claims 1 described dysmenorrhes.(2) ketotifen fumarate, stevioside are mixed by the equivalent incremental method with starch, behind the mix homogeneously that sieves, with the abundant mixing of other adjuvants.(3) be wetting agent with 50% ethanol, add in the mixture, make suitable soft material.(4) granulate with 24 order nylon mesh.(5) wet grain spreads out in the dish, is controlled at 50 ℃ of dryings.(6) dried granule adds Pulvis Talci, magnesium stearate mixing.(7) tabletting gets 1000, and packing promptly gets the ketotifen fumarate dispersible tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031287883A CN100471495C (en) | 2003-05-11 | 2003-05-11 | Fumaric acid-ketotifen dispersion tablet and its prepn process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031287883A CN100471495C (en) | 2003-05-11 | 2003-05-11 | Fumaric acid-ketotifen dispersion tablet and its prepn process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1548044A true CN1548044A (en) | 2004-11-24 |
| CN100471495C CN100471495C (en) | 2009-03-25 |
Family
ID=34322248
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB031287883A Expired - Lifetime CN100471495C (en) | 2003-05-11 | 2003-05-11 | Fumaric acid-ketotifen dispersion tablet and its prepn process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100471495C (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104059056A (en) * | 2014-06-26 | 2014-09-24 | 福建省闽东力捷迅药业有限公司 | New crystal form B of fumarate rupatifen and preparation method thereof |
| CN106420637A (en) * | 2015-08-04 | 2017-02-22 | 常州制药厂有限公司 | Ketotifen fumarate tablets and preparation method thereof |
| CN108567756A (en) * | 2018-06-25 | 2018-09-25 | 江苏鹏鹞药业有限公司 | Determination of Ketotifen Fumarate Tablets and preparation method thereof |
| CN110638769A (en) * | 2019-10-25 | 2020-01-03 | 仁和堂药业有限公司 | Production method of ketotifen fumarate tablets |
| CN110664767A (en) * | 2019-10-25 | 2020-01-10 | 仁和堂药业有限公司 | Ketotifen fumarate tablet and application thereof |
-
2003
- 2003-05-11 CN CNB031287883A patent/CN100471495C/en not_active Expired - Lifetime
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104059056A (en) * | 2014-06-26 | 2014-09-24 | 福建省闽东力捷迅药业有限公司 | New crystal form B of fumarate rupatifen and preparation method thereof |
| CN104059056B (en) * | 2014-06-26 | 2017-08-25 | 福建省闽东力捷迅药业有限公司 | A kind of fumaric acid Lu handkerchief replaces fragrant crystal formation B and preparation method thereof |
| CN106420637A (en) * | 2015-08-04 | 2017-02-22 | 常州制药厂有限公司 | Ketotifen fumarate tablets and preparation method thereof |
| CN106420637B (en) * | 2015-08-04 | 2019-11-01 | 常州制药厂有限公司 | A kind of Determination of Ketotifen Fumarate Tablets and preparation method thereof |
| CN108567756A (en) * | 2018-06-25 | 2018-09-25 | 江苏鹏鹞药业有限公司 | Determination of Ketotifen Fumarate Tablets and preparation method thereof |
| CN110638769A (en) * | 2019-10-25 | 2020-01-03 | 仁和堂药业有限公司 | Production method of ketotifen fumarate tablets |
| CN110664767A (en) * | 2019-10-25 | 2020-01-10 | 仁和堂药业有限公司 | Ketotifen fumarate tablet and application thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100471495C (en) | 2009-03-25 |
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|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CX01 | Expiry of patent term | ||
| CX01 | Expiry of patent term |
Granted publication date: 20090325 |