CN108567756A - Determination of Ketotifen Fumarate Tablets and preparation method thereof - Google Patents
Determination of Ketotifen Fumarate Tablets and preparation method thereof Download PDFInfo
- Publication number
- CN108567756A CN108567756A CN201810661611.9A CN201810661611A CN108567756A CN 108567756 A CN108567756 A CN 108567756A CN 201810661611 A CN201810661611 A CN 201810661611A CN 108567756 A CN108567756 A CN 108567756A
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- CN
- China
- Prior art keywords
- ketotifen fumarate
- parts
- freeze
- drying
- ketotifen
- 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.)
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/4535—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
Abstract
The invention discloses Determination of Ketotifen Fumarate Tablets, including following mass fraction：1 ~ 2 part of 50 ~ 80 parts of Ketotifen Fumarate, 5 ~ 10 parts of hydroxypropyl cellulose, 1 ~ 5 part of magnesium stearate and starch.Meanwhile the invention also discloses the preparation methods of above-mentioned Determination of Ketotifen Fumarate Tablets.The present invention reduces the heat source risk in Ketotifen Fumarate raw material, in later stage preparation process, persistently uses low temperature preparation, further having prevented may existing for heat source by being pre-processed at low ambient temperatures to Ketotifen Fumarate.
Description
Technical field
The invention belongs to field of medicaments, and in particular to a kind of Determination of Ketotifen Fumarate Tablets and preparation method thereof.
Background technology
Ketotifen Fumarate is second generation histamine H 1 receptor antagonist, has stronger histamine H1-receptor antagonism, in
It lists within 1979, in Europe, Asia, many areas such as Australia use, and pharmacopeia version in 2000 in China's records its tablet.Rich horse
Sour Ketotifen clinic is mainly used for prevention and the quality of allergic asthma and allergic rhinitis asthmatic syndrome, it is considered to be a kind of
With steroids sample effect but without the drug of steroids side effect.Ketotifen Fumarate is especially pronounced to the treatment of childhood asthma,
Curative effect is up to 80% or more.Currently, Ketotifen Fumarate is chiefly used in nasal mist or tablet, since object part is children, use
Spray such as misoperation can cause discomfort, and it is not recommended that use；And using there are heat source influences if tablet, leather can be caused blue
The infringement of family name's positive bacteria.
Invention content
Goal of the invention：In view of the above-mentioned deficiencies in the prior art, it is an object of the present invention to provide a kind of Determination of Ketotifen Fumarate Tablets.
Another object of the present invention is to provide the preparation methods of above-mentioned Ketotifen Fumarate.
Technical solution：In order to reach foregoing invention purpose, what the present invention was specifically performed by：Ketotifen Fumarate
Piece, including following mass fraction：50 ~ 80 parts of Ketotifen Fumarate, 5 ~ 10 parts of hydroxypropyl cellulose, 1 ~ 5 part of magnesium stearate and shallow lake
1 ~ 2 part of powder.
A kind of optimum ratio, by 60 parts of Ketotifen Fumarate of mass fraction, 8 parts of hydroxypropyl cellulose, 3 parts of tristearin
Sour magnesium and 1 part of starch composition.
Determination of Ketotifen Fumarate Tablets is prepared, is included the following steps：
（1）Ketotifen Fumarate pre-processes：Ketotifen Fumarate is taken to be dissolved in distilled water under room temperature, using centrifugal mixer 20 ~ 40
The addition mass ratio of minute, formation ketotifen fumarate solution, Ketotifen Fumarate and distilled water is 1:15 ~ 20, by fumaric acid
Ketotifen solutions carry out vacuum filtration crystallization at 0 ~ 5 DEG C, Ketotifen Fumarate after crystallization be sent into freeze drying box and vacuumize into
Row freeze-drying, freeze-drying are divided into and carrying out three times ,≤- 30 DEG C of freeze-drying control for the first time, control time 6 ~ 8 hours, and secondary freeze-drying is warming up to≤-
15 DEG C of control times 8 ~ 10 hours, three times freeze-drying are warming up to 0 DEG C of control time 10 ~ 12 hours；
（2）Under conditions of≤10 DEG C, Ketotifen Fumarate, hydroxypropyl cellulose, magnesium stearate and starch are sieved respectively, selected
It is sieved with 60 mesh, is mixed 10 ~ 20 minutes afterwards, be passed through tablet press machine and carry out tabletting, 5 ~ 15kN of control pressure.
Advantageous effect：The present invention is compared with traditional technology, by being located in advance to Ketotifen Fumarate at low ambient temperatures
Reason, reduces the heat source risk in Ketotifen Fumarate raw material, in later stage preparation process, low temperature preparation is persistently used, into one
Step has prevented may existing for heat source.
Specific implementation mode
Embodiment 1：
Determination of Ketotifen Fumarate Tablets is by 50 parts of mass fraction Ketotifen Fumarate, 5 parts of hydroxypropyl cellulose, 1 part of magnesium stearate and shallow lake
1 part of composition of powder.
Embodiment 2：
Determination of Ketotifen Fumarate Tablets is by 80 parts of mass fraction Ketotifen Fumarate, 10 parts of hydroxypropyl cellulose, 5 parts of magnesium stearate and shallow lake
2 parts of compositions of powder.
Embodiment 3：
Determination of Ketotifen Fumarate Tablets is by 60 parts of mass fraction Ketotifen Fumarate, 7 parts of hydroxypropyl cellulose, 2 parts of magnesium stearate and shallow lake
1 part of composition of powder.
Embodiment 4：
Determination of Ketotifen Fumarate Tablets is by 70 parts of mass fraction Ketotifen Fumarate, 9 parts of hydroxypropyl cellulose, 4 parts of magnesium stearate and shallow lake
2 parts of compositions of powder.
Embodiment 5：
Determination of Ketotifen Fumarate Tablets preparation method, includes the following steps：
（1）Ketotifen Fumarate pre-processes：Ketotifen Fumarate is taken to be dissolved in distilled water under room temperature, using centrifugal mixer 20 ~ 40
The addition mass ratio of minute, formation ketotifen fumarate solution, Ketotifen Fumarate and distilled water is 1:15 ~ 20, by fumaric acid
Ketotifen solutions carry out vacuum filtration crystallization at 0 ~ 5 DEG C, Ketotifen Fumarate after crystallization be sent into freeze drying box and vacuumize into
Row freeze-drying, freeze-drying are divided into and carrying out three times ,≤- 30 DEG C of freeze-drying control for the first time, control time 6 ~ 8 hours, and secondary freeze-drying is warming up to≤-
15 DEG C of control times 8 ~ 10 hours, three times freeze-drying are warming up to 0 DEG C of control time 10 ~ 12 hours；
（2）Under conditions of≤10 DEG C, Ketotifen Fumarate, hydroxypropyl cellulose, magnesium stearate and starch are sieved respectively, selected
It is sieved with 60 mesh, is mixed 10 ~ 20 minutes afterwards, be passed through tablet press machine and carry out tabletting, 5 ~ 15kN of control pressure.
Embodiment 6：
Reference implementation example 5 is heated up in the form of 2 DEG C/10 ~ 15 minutes between freeze-drying process three times, rises to demand temperature
Degree.
Claims (3)
1. Determination of Ketotifen Fumarate Tablets, which is characterized in that including following mass fraction：50 ~ 80 parts of Ketotifen Fumarate, hydroxypropyl are fine
1 ~ 2 part of 5 ~ 10 parts of dimension element, 1 ~ 5 part of magnesium stearate and starch.
2. Determination of Ketotifen Fumarate Tablets according to claim 1, which is characterized in that replaced by 60 parts of fumaric acid ketone of mass fraction
Sweet smell, 8 parts of hydroxypropyl cellulose, 3 parts of magnesium stearate and 1 part of starch composition.
3. preparing Determination of Ketotifen Fumarate Tablets described in claims 1 or 2, which is characterized in that include the following steps：
（1）Ketotifen Fumarate pre-processes：Ketotifen Fumarate is taken to be dissolved in distilled water under room temperature, using centrifugal mixer 20 ~ 40
The addition mass ratio of minute, formation ketotifen fumarate solution, Ketotifen Fumarate and distilled water is 1:15 ~ 20, by fumaric acid
Ketotifen solutions carry out vacuum filtration crystallization at 0 ~ 5 DEG C, Ketotifen Fumarate after crystallization be sent into freeze drying box and vacuumize into
Row freeze-drying, freeze-drying are divided into and carrying out three times ,≤- 30 DEG C of freeze-drying control for the first time, control time 6 ~ 8 hours, and secondary freeze-drying is warming up to≤-
15 DEG C of control times 8 ~ 10 hours, three times freeze-drying are warming up to 0 DEG C of control time 10 ~ 12 hours；
（2）Under conditions of≤10 DEG C, Ketotifen Fumarate, hydroxypropyl cellulose, magnesium stearate and starch are sieved respectively, selected
It is sieved with 60 mesh, is mixed 10 ~ 20 minutes afterwards, be passed through tablet press machine and carry out tabletting, 5 ~ 15kN of control pressure.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810661611.9A CN108567756A (en) | 2018-06-25 | 2018-06-25 | Determination of Ketotifen Fumarate Tablets and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810661611.9A CN108567756A (en) | 2018-06-25 | 2018-06-25 | Determination of Ketotifen Fumarate Tablets and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN108567756A true CN108567756A (en) | 2018-09-25 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
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| CN201810661611.9A Pending CN108567756A (en) | 2018-06-25 | 2018-06-25 | Determination of Ketotifen Fumarate Tablets and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1548044A (en) * | 2003-05-11 | 2004-11-24 | 山东绿因药业有限公司 | Fumaric acid-ketotifen dispersion tablet and its prepn process |
| JP2010270112A (en) * | 2009-04-21 | 2010-12-02 | Taisho Pharmaceutical Co Ltd | Ketotifen or solid preparation containing salt thereof with improved dissolution |
| CN104305202A (en) * | 2014-11-06 | 2015-01-28 | 河北考力森生物科技有限公司 | Ultrafine moringa oleifera powder compressed buccal tablet, 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 |
-
2018
- 2018-06-25 CN CN201810661611.9A patent/CN108567756A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1548044A (en) * | 2003-05-11 | 2004-11-24 | 山东绿因药业有限公司 | Fumaric acid-ketotifen dispersion tablet and its prepn process |
| JP2010270112A (en) * | 2009-04-21 | 2010-12-02 | Taisho Pharmaceutical Co Ltd | Ketotifen or solid preparation containing salt thereof with improved dissolution |
| CN104305202A (en) * | 2014-11-06 | 2015-01-28 | 河北考力森生物科技有限公司 | Ultrafine moringa oleifera powder compressed buccal tablet, 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 |
Non-Patent Citations (1)
| Title |
|---|
| 杨青莲 等: "气温对热原反应的影响", 《人民军医》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20180925 |