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Ketotifen fumarate tablets and preparation method thereof

A technology of ketotifen fumarate and calcium hydrogen phosphate, which can be used in pharmaceutical formulations, medical preparations containing active ingredients, and pill delivery, and can solve the problem of low bioavailability

Active Publication Date: 2017-02-22
CHANGZHOU PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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  • Ketotifen fumarate tablets and preparation method thereof

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Embodiment 1

[0015] Ketotifen fumarate tablet prescription and preparation method thereof (calculated in 1000 tablets)

[0016] Element quality Ketotifen Fumarate 1.38g pregelatinized starch 22.59g lactose 35.60g Calcium hydrogen phosphate 9.82g Hydroxypropylmethylcellulose 2.15g Magnesium stearate 0.83g microcrystalline cellulose 1.56g 50% ethanol Appropriate amount

[0017] According to the above prescription, weigh the ketotifen fumarate fine powder, pregelatinized starch, lactose, calcium hydrogen phosphate, and microcrystalline cellulose that have been ultrafinely pulverized and passed through a 200-mesh sieve, mix thoroughly for 60 minutes, and add hydroxypropyl methylcellulose Vegetables, appropriate amount of 50% ethanol soft material, sieved and granulated. Then dry the wet granules at 65-75°C, sieve the dried granules for granulation, add magnesium stearate, mix for 30 minutes, and press into tablets to obtain the p...

Embodiment 2

[0019] Ketotifen fumarate tablet prescription and preparation method thereof (calculated in 1000 tablets)

[0020] Element quality Ketotifen Fumarate 1.38g starch 45.50g dextrin 18.98g Calcium hydrogen phosphate 10.25g Hydroxypropylmethylcellulose 2.43g talcum powder 0.89g microcrystalline cellulose 1.50g 50% ethanol Appropriate amount

[0021] According to the above prescription, take the ketotifen fumarate fine powder, starch, dextrin, calcium hydrogen phosphate, and microcrystalline cellulose that have been ultrafinely pulverized and passed through a 200-mesh sieve, mix thoroughly for 60 minutes, and add hydroxypropyl methylcellulose fine powder. Powder, appropriate amount of 50% ethanol soft material, sieved and granulated. Then dry the wet granules at 65-75°C, sieve the dried granules for granulation, add talc powder, mix for 30 minutes, and press into tablets to obtain the product.

Embodiment 3

[0023] Ketotifen fumarate tablet prescription and preparation method thereof (calculated in 1000 tablets)

[0024] Element quality Ketotifen Fumarate 1.38g starch 40.88g lactose 18.47g Calcium hydrogen phosphate 10.65g Hydroxypropylmethylcellulose 2.50g Magnesium stearate 1.00g Sodium carboxymethyl starch 2.86g 50% ethanol Appropriate amount

[0025] According to the above prescription, take the ketotifen fumarate fine powder, starch, lactose, calcium hydrogen phosphate, and sodium carboxymethyl starch that have been ultrafinely pulverized and passed through a 200-mesh sieve, mix thoroughly for 60 minutes, add hydroxypropyl methylcellulose, Appropriate amount of 50% ethanol to make soft material, sieve and granulate. Then dry the wet granules at 65-75°C, sieve the dried granules for granulation, add magnesium stearate, mix for 30 minutes, and press into tablets to obtain the product.

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Abstract

The invention provides ketotifen fumarate tablets. The ketotifen fumarate tablets are prepared by adopting superfine grinding technology and tablet process technology and are high in dissolution rate, lasting in action, few in administration times, stable in blood-drug concentration and higher in safety, and treatment effect of the ketotifen fumarate tablets is brought into full play.

Description

technical field [0001] The invention relates to a ketotifen fumarate tablet and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Ketotifen (Ketotifen) is an oral potent allergic transmitter release agent, commonly used as its fumarate, and is an anti-allergic drug. The drug can not only inhibit the antigen-induced release of histamine and allergic slow-response substance (SRS-A) from mast cells in the lung and bronchial tissue, but also inhibit the induction of eosinophils or neutrophils by antigens, serum or calcium ion transmitters. Slow-reacting substances that release histamine and allergies. The drug has a strong H1 receptor antagonistic effect and can antagonize 5-hydroxytryptamine and allergic slow-response substances. Studies have found that the drug can inhibit non-specific airway hyperresponsiveness in patients with bronchial asthma, and antagonize bronchospasm caused by allergens, histamine, carbo...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4535A61P37/08A61P11/02A61P11/06A61P17/00
Inventor 陈永红吴路新巫美金宋光西朱玲玲
Owner CHANGZHOU PHARMA FACTORY
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