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
- ketotifen
- tablets
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- YNQQEYBLVYAWNX-WLHGVMLRSA-N ketotifen fumarate Chemical compound OC(=O)\C=C\C(O)=O.C1CN(C)CCC1=C1C2=CC=CC=C2CC(=O)C2=C1C=CS2 YNQQEYBLVYAWNX-WLHGVMLRSA-N 0.000 title claims abstract description 31
- 229960003630 ketotifen fumarate Drugs 0.000 title claims abstract description 31
- 238000002360 preparation method Methods 0.000 title claims description 10
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 17
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 12
- 235000019441 ethanol Nutrition 0.000 claims description 8
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 7
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 7
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 7
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 7
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 6
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 claims description 6
- 235000019700 dicalcium phosphate Nutrition 0.000 claims description 6
- 239000008101 lactose Substances 0.000 claims description 6
- 235000019359 magnesium stearate Nutrition 0.000 claims description 6
- 239000000843 powder Substances 0.000 claims description 5
- 235000020985 whole grains Nutrition 0.000 claims description 5
- 206010013786 Dry skin Diseases 0.000 claims description 4
- 229920000881 Modified starch Polymers 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 4
- 239000008188 pellet Substances 0.000 claims description 4
- 239000011122 softwood Substances 0.000 claims description 4
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 3
- 238000005469 granulation Methods 0.000 claims description 3
- 230000003179 granulation Effects 0.000 claims description 3
- 238000007873 sieving Methods 0.000 claims description 3
- 238000002156 mixing Methods 0.000 claims description 2
- 239000000835 fiber Substances 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 238000004090 dissolution Methods 0.000 abstract description 9
- 238000000034 method Methods 0.000 abstract description 6
- 238000004891 communication Methods 0.000 abstract description 4
- 238000005516 engineering process Methods 0.000 abstract description 4
- 230000001225 therapeutic effect Effects 0.000 abstract description 4
- 210000004369 blood Anatomy 0.000 abstract description 3
- 239000008280 blood Substances 0.000 abstract description 3
- 230000002085 persistent effect Effects 0.000 abstract description 2
- 229920002472 Starch Polymers 0.000 description 10
- 239000008107 starch Substances 0.000 description 10
- 235000019698 starch Nutrition 0.000 description 10
- NTYJJOPFIAHURM-UHFFFAOYSA-N Histamine Chemical compound NCCC1=CN=CN1 NTYJJOPFIAHURM-UHFFFAOYSA-N 0.000 description 6
- ZCVMWBYGMWKGHF-UHFFFAOYSA-N Ketotifene Chemical compound C1CN(C)CCC1=C1C2=CC=CC=C2CC(=O)C2=C1C=CS2 ZCVMWBYGMWKGHF-UHFFFAOYSA-N 0.000 description 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 6
- 208000026935 allergic disease Diseases 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- 229960004958 ketotifen Drugs 0.000 description 6
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 6
- 239000008108 microcrystalline cellulose Substances 0.000 description 6
- 229940016286 microcrystalline cellulose Drugs 0.000 description 6
- 206010020751 Hypersensitivity Diseases 0.000 description 5
- 230000007815 allergy Effects 0.000 description 5
- 229920001353 Dextrin Polymers 0.000 description 3
- 239000004375 Dextrin Substances 0.000 description 3
- 230000008485 antagonism Effects 0.000 description 3
- 208000006673 asthma Diseases 0.000 description 3
- 208000010668 atopic eczema Diseases 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- 235000019425 dextrin Nutrition 0.000 description 3
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 229960001340 histamine Drugs 0.000 description 3
- 210000003630 histaminocyte Anatomy 0.000 description 3
- 239000004615 ingredient Substances 0.000 description 3
- 208000030603 inherited susceptibility to asthma Diseases 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 238000010298 pulverizing process Methods 0.000 description 3
- 239000011734 sodium Substances 0.000 description 3
- 229910052708 sodium Inorganic materials 0.000 description 3
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- 201000004624 Dermatitis Diseases 0.000 description 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 2
- 206010039085 Rhinitis allergic Diseases 0.000 description 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 2
- 239000000853 adhesive Substances 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 2
- 230000000172 allergic effect Effects 0.000 description 2
- 201000010105 allergic rhinitis Diseases 0.000 description 2
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 2
- 239000000427 antigen Substances 0.000 description 2
- 102000036639 antigens Human genes 0.000 description 2
- 108091007433 antigens Proteins 0.000 description 2
- 239000011575 calcium Substances 0.000 description 2
- 229910052791 calcium Inorganic materials 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 229910052739 hydrogen Inorganic materials 0.000 description 2
- 239000001257 hydrogen Substances 0.000 description 2
- 238000000338 in vitro Methods 0.000 description 2
- 230000002757 inflammatory effect Effects 0.000 description 2
- 210000004185 liver Anatomy 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- 210000004072 lung Anatomy 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N phosphoric acid Substances OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- -1 phosphoric acid hydrogen Chemical class 0.000 description 2
- 230000004044 response Effects 0.000 description 2
- QZAYGJVTTNCVMB-UHFFFAOYSA-N serotonin Chemical compound C1=C(O)C=C2C(CCN)=CNC2=C1 QZAYGJVTTNCVMB-UHFFFAOYSA-N 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 208000009079 Bronchial Spasm Diseases 0.000 description 1
- 206010006482 Bronchospasm Diseases 0.000 description 1
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 1
- 229920002785 Croscarmellose sodium Polymers 0.000 description 1
- 206010059866 Drug resistance Diseases 0.000 description 1
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 1
- 102000003834 Histamine H1 Receptors Human genes 0.000 description 1
- 108090000110 Histamine H1 Receptors Proteins 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- 206010033645 Pancreatitis Diseases 0.000 description 1
- 206010033647 Pancreatitis acute Diseases 0.000 description 1
- 229920002701 Polyoxyl 40 Stearate Polymers 0.000 description 1
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 description 1
- 206010041349 Somnolence Diseases 0.000 description 1
- 208000024780 Urticaria Diseases 0.000 description 1
- 235000010489 acacia gum Nutrition 0.000 description 1
- 239000001785 acacia senegal l. willd gum Substances 0.000 description 1
- OIPILFWXSMYKGL-UHFFFAOYSA-N acetylcholine Chemical compound CC(=O)OCC[N+](C)(C)C OIPILFWXSMYKGL-UHFFFAOYSA-N 0.000 description 1
- 229960004373 acetylcholine Drugs 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 201000003229 acute pancreatitis Diseases 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 230000003266 anti-allergic effect Effects 0.000 description 1
- 229910001424 calcium ion Inorganic materials 0.000 description 1
- 239000001569 carbon dioxide Substances 0.000 description 1
- 229910002092 carbon dioxide Inorganic materials 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 235000013339 cereals Nutrition 0.000 description 1
- 229960001681 croscarmellose sodium Drugs 0.000 description 1
- 229960000913 crospovidone Drugs 0.000 description 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000004064 dysfunction Effects 0.000 description 1
- 210000003979 eosinophil Anatomy 0.000 description 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 description 1
- 230000029142 excretion Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 230000010224 hepatic metabolism Effects 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- 210000004493 neutrocyte Anatomy 0.000 description 1
- 210000000496 pancreas Anatomy 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 235000011007 phosphoric acid Nutrition 0.000 description 1
- 229940099429 polyoxyl 40 stearate Drugs 0.000 description 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 229940069328 povidone Drugs 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 206010039083 rhinitis Diseases 0.000 description 1
- 229940076279 serotonin Drugs 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
- 235000017281 sodium acetate Nutrition 0.000 description 1
- 229960004249 sodium acetate Drugs 0.000 description 1
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- DPJRMOMPQZCRJU-UHFFFAOYSA-M thiamine hydrochloride Chemical compound Cl.[Cl-].CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N DPJRMOMPQZCRJU-UHFFFAOYSA-M 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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.
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| 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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|---|---|---|---|
| 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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| CN106420637B true CN106420637B (en) | 2019-11-01 |
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| 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 |
-
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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