CN106420637B - A kind of Determination of Ketotifen Fumarate Tablets and preparation method thereof - Google Patents
A kind of Determination of Ketotifen Fumarate Tablets and preparation method thereof Download PDFInfo
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- CN106420637B CN106420637B CN201510481286.4A CN201510481286A CN106420637B CN 106420637 B CN106420637 B CN 106420637B CN 201510481286 A CN201510481286 A CN 201510481286A CN 106420637 B CN106420637 B CN 106420637B
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- ketotifen fumarate
- fumarate tablets
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Abstract
The present invention prepares Determination of Ketotifen Fumarate Tablets using superfine communication technique and tablet technology, provide it is a kind of have that high-dissolution, persistent, medicining times are few, blood concentration is steady, the higher Determination of Ketotifen Fumarate Tablets of safety, so that the therapeutic effect of Determination of Ketotifen Fumarate Tablets is given full play to.
Description
Technical field
The present invention relates to a kind of Determination of Ketotifen Fumarate Tablets and preparation method thereof, belong to field of pharmaceutical preparations.
Background technique
Ketotifen (Ketotifen) is to take orally potent allergy mediator sustained-release agent, commonly uses its fumarate, is antiallergic action
Class drug.The medicine can not only inhibit the slow reacting substance of antigen induced lung and bronchial tissue's histamine release of mast cell and allergy
(SRS-A), and can also inhibit antigen, serum or calcium ion mediator induce eosinophils or neutrophil leucocyte release histamine and
The slow reacting substance of allergy.The medical instrument has stronger H1 receptor antagonism, the long response time object of energy antagonism serotonin and allergy
Matter.Studies have found that the medicine can inhibit the non-specific airway high response of Bronchial Asthmas, antagonism anaphylactogen, histamine,
Bronchial spasm caused by carbon dioxide, acetylcholine etc..Ketotifen blood medicine effective concentration be 1.4mg/L, mainly through liver, kidney and
Lung excretion, clinical effectiveness can be shown for 2~3 weeks by being used in conjunction, and therapeutic effect in 6~12 weeks is most strong, and duration of efficacy is longer, for a long time
Using drug resistance is not generated, treatment is interrupted also without rebound phenomenon, adverse reaction occurs less, it is seen that drowsiness, out of strength, dry, stomach
Enteron aisle reaction etc., occasionally there is dysfunction of liver.Ketotifen obtains in respiratory system, rhinitis, nettle rash and allergic disease
To clinical extensive use, clinic is suitable for allergic rhinitis and allergic bronchial asthma.Research also found recently, Ketotifen
The degranulation that can inhibit mast cell by stablizing mast cell membrane in Severe Acute Pancreatitis SAP (SAP) treatment, reduces inflammatory
The release of mediator and cell factor and play inhibit pancreas inflammatory aggravate and alleviate symptom effect.
It is absorbed after current market sales of Determination of Ketotifen Fumarate Tablets is oral from gastrointestinal tract, but is disintegrated too long in this world, action
Relatively slow, medication several weeks side display effect is most of in liver metabolism.Metabolin and a small amount of raw material are drained by urine and excrement.Biology
Availability is lower.Acting duration is longer, only needs within 1st to be administered 2 times.
Summary of the invention
It in order to make tablet fater disintegration, absorbs rapidly, dissolution rate is accelerated, and bioavilability provides, we are to tablet
Production technology is improved, and Determination of Ketotifen Fumarate Tablets is prepared using superfine communication technique and tablet technology, to overcome
The shortcomings that existing tablet technology and deficiency, providing a kind of has that high-dissolution, persistent, medicining times are few, blood concentration
Steadily, the higher Determination of Ketotifen Fumarate Tablets of safety enables the therapeutic effect of Determination of Ketotifen Fumarate Tablets to give full play to.
For achieving the above object, The technical solution adopted by the invention is as follows:
A kind of Determination of Ketotifen Fumarate Tablets and preparation method thereof, it is characterised in that: select Ketotifen Fumarate, calcium monohydrogen phosphate,
Filler, adhesive, lubricant, disintegrating agent, 50% appropriate amount of ethanol.By Ketotifen Fumarate first individually through pulverizing, then
It mixed, pelletized with auxiliary material, being dried, whole grain, mixed pressuring plate, for controlling for allergic rhinitis and allergic bronchial asthma
It treats, it can also be used to the diseases such as a variety of allergy dermatitis, eczema.
The high-dissolution Determination of Ketotifen Fumarate Tablets that superfine communication technique preparation is used in the present invention includes following quality percentage
Several components:
Filler used in the present invention can be selected from starch, pregelatinized starch, lactose, dextrin, microcrystalline cellulose or it is mixed
Close object.
Described adhesive is selected from starch, povidone, hydroxypropyl cellulose, methylcellulose, sodium carboxymethylcellulose, bright
Or mixtures thereof glue, Arabic gum.
The lubricant be selected from magnesium stearate, talcum powder, polyoxyl 40 stearate, sodium acetate, sodium stearyl fumarate,
Or mixtures thereof sodium benzoate, enuatrol.
The disintegrating agent be selected from microcrystalline cellulose, sodium carboxymethyl starch, hydroxypropul starch, croscarmellose sodium,
Or mixtures thereof crospovidone.
Specific embodiment
The following example cannot be limited the scope of the invention for being explained further or understanding the contents of the present invention.
Embodiment 1:
Determination of Ketotifen Fumarate Tablets prescription and preparation method thereof (in terms of 1000)
| Ingredient | Quality |
| Ketotifen Fumarate | 1.38g |
| Pregelatinized starch | 22.59g |
| Lactose | 35.60g |
| Calcium monohydrogen phosphate | 9.82g |
| Hydroxypropyl methyl cellulose | 2.15g |
| Magnesium stearate | 0.83g |
| Microcrystalline cellulose | 1.56g |
| 50% ethyl alcohol | In right amount |
Weighed by above-mentioned prescription pulverized the Ketotifen Fumarate fine powder of 200 meshes, pregelatinized starch, lactose,
Calcium monohydrogen phosphate, microcrystalline cellulose are sufficiently mixed 60 minutes, and hydroxypropyl methyl cellulose, appropriate 50% ethyl alcohol softwood, mistake is added
Sieve granulation.Then magnesium stearate, mixing 30 is added after 65~75 DEG C of dryings, dry gained pellet through sieves whole grain in wet granular
Minute after tabletting to get.
Embodiment 2:
Determination of Ketotifen Fumarate Tablets prescription and preparation method thereof (in terms of 1000)
| Ingredient | Quality |
| Ketotifen Fumarate | 1.38g |
| Starch | 45.50g |
| Dextrin | 18.98g |
| Calcium monohydrogen phosphate | 10.25g |
| Hydroxypropyl methyl cellulose | 2.43g |
| Talcum powder | 0.89g |
| Microcrystalline cellulose | 1.50g |
| 50% ethyl alcohol | In right amount |
It weighs by above-mentioned prescription through pulverizing the Ketotifen Fumarate fine powder of 200 meshes, starch, dextrin, phosphoric acid hydrogen
Calcium, microcrystalline cellulose are sufficiently mixed 60 minutes, and hydroxypropyl methyl cellulose fine powder, appropriate 50% ethyl alcohol softwood, sieving is added
Granulation.Then wet granular is added talcum powder, mixed 30 minutes after 65~75 DEG C of dryings, dry gained pellet through sieves whole grain
Afterwards tabletting to get.
Embodiment 3:
Determination of Ketotifen Fumarate Tablets prescription and preparation method thereof (in terms of 1000)
| Ingredient | Quality |
| Ketotifen Fumarate | 1.38g |
| Starch | 40.88g |
| Lactose | 18.47g |
| Calcium monohydrogen phosphate | 10.65g |
| Hydroxypropyl methyl cellulose | 2.50g |
| Magnesium stearate | 1.00g |
| Sodium carboxymethyl starch | 2.86g |
| 50% ethyl alcohol | In right amount |
It weighs by above-mentioned prescription through pulverizing the Ketotifen Fumarate fine powder of 200 meshes, starch, lactose, phosphoric acid hydrogen
Calcium, sodium carboxymethyl starch are sufficiently mixed 60 minutes, and hydroxypropyl methyl cellulose, appropriate 50% ethyl alcohol softwood, sieving system is added
Grain.Then wet granular is added magnesium stearate, mixed 30 minutes after 65~75 DEG C of dryings, dry gained pellet through sieves whole grain
Afterwards tabletting to get.
Embodiment 4
The Determination of Ketotifen Fumarate Tablets of superfine communication technique preparation is compared with commercially available Determination of Ketotifen Fumarate Tablets dissolution in vitro
According to the dissolution determination method of 2010 editions defineds of Chinese Pharmacopoeia, 1,2,3 tablet of comparing embodiment and commercially available richness
Horse acid Ketotifen piece dissolution in vitro.Dissolution determination result is as follows at 40 minutes:
| Sample | Dissolution rate (%) |
| 1 tablet of embodiment | 92.8% |
| 2 tablet of embodiment | 89.7% |
| 3 tablet of embodiment | 90.4% |
| Commercially available Determination of Ketotifen Fumarate Tablets | 83.6% |
In conclusion Determination of Ketotifen Fumarate Tablets prepared by the present invention, significantly improves the external molten of Determination of Ketotifen Fumarate Tablets
Out-degree enables the therapeutic effect of Determination of Ketotifen Fumarate Tablets to give full play to can increase the bioavilability of drug.
Claims (1)
1. a kind of preparation method of Determination of Ketotifen Fumarate Tablets, it is characterised in that the following steps are included:
It weighs and was pulverized the Ketotifen Fumarate fine powder of 200 meshes, pregelatinized starch, lactose, calcium monohydrogen phosphate, crystallite fibre
Dimension element, is sufficiently mixed 60 minutes, hydroxypropyl methyl cellulose, appropriate 50% ethyl alcohol softwood is added, sieving granulation then will be wet
After dry gained pellet through sieves whole grain, magnesium stearate is added in 65~75 DEG C of dryings in particle, after mixing 30 minutes tabletting to get.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510481286.4A CN106420637B (en) | 2015-08-04 | 2015-08-04 | A kind of Determination of Ketotifen Fumarate Tablets and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510481286.4A CN106420637B (en) | 2015-08-04 | 2015-08-04 | A kind of Determination of Ketotifen Fumarate Tablets and preparation method thereof |
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| Publication Number | Publication Date |
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| CN106420637A CN106420637A (en) | 2017-02-22 |
| CN106420637B true CN106420637B (en) | 2019-11-01 |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN110664767A (en) * | 2019-10-25 | 2020-01-10 | 仁和堂药业有限公司 | Ketotifen fumarate tablet and application thereof |
| CN110638769A (en) * | 2019-10-25 | 2020-01-03 | 仁和堂药业有限公司 | Production method of ketotifen fumarate tablets |
Citations (2)
| 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 |
| CN1602868A (en) * | 2004-08-23 | 2005-04-06 | 南昌弘益科技有限公司 | Dripping pills of ketotifen fumarate and its preparation method |
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2015
- 2015-08-04 CN CN201510481286.4A patent/CN106420637B/en active Active
Patent Citations (2)
| 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 |
| CN1602868A (en) * | 2004-08-23 | 2005-04-06 | 南昌弘益科技有限公司 | Dripping pills of ketotifen fumarate and its preparation method |
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| CN106420637A (en) | 2017-02-22 |
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