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Oral tablet with tofisopam as active ingredient, and application of oral tablet

A technology of tofisopam and oral tablet, applied in the field of medicine, can solve the problems of not having sedative, anticonvulsant and muscle relaxation properties and the like

Inactive Publication Date: 2013-09-18
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tofisopam has selective anxiolytic effects, but does not have the sedative, anticonvulsant and muscle relaxant properties of general benzodiazepines

Method used

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  • Oral tablet with tofisopam as active ingredient, and application of oral tablet
  • Oral tablet with tofisopam as active ingredient, and application of oral tablet
  • Oral tablet with tofisopam as active ingredient, and application of oral tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Make 1000 tofisopam tablets with the raw materials of following weight ratio.

[0016]

[0017] Preparation Process:

[0018] 1. Tofisopam crude drug is pulverized and passed through an 80-mesh sieve, and set aside.

[0019] 2. Pass the lactose through a 60-mesh sieve and set aside.

[0020] 3. Take tofisopam and mix well with microcrystalline cellulose, lactose, calcium hydrogen phosphate and croscarmellose sodium.

[0021] 4. Make soft material with water, granulate with 20 mesh sieve, dry at 60°C, and granulate with 24 mesh sieve.

[0022] 5. Add magnesium stearate, mix well, and press into tablets.

Embodiment 2

[0024] 1. Prepare 6% ethanol solution of Opadry enteric coating agent;

[0025] 2. Take the plain tablet obtained in Example 1, pour it into the coating pan, start the coating pan, and blow hot air, preheat the plain tablet at 30-40°C for 10 minutes, and blow off the drug powder adhering to the tablet core, Spray the coating solution evenly, so that the drug solution is evenly coated on the tablet core, and the tofisopam enteric-coated tablet is obtained.

Embodiment 3

[0027] Make 1000 tofisopam tablets with the raw material of following weight ratio.

[0028]

[0029] Preparation:

[0030] 1. Grind Pirfenib and raw materials through an 80-mesh sieve, and set aside.

[0031] 2. Pass the lactose through a 60-mesh sieve and set aside.

[0032] 3. Take tofisopam, sorbitol, microcrystalline cellulose, croscarmellose sodium, and highly substituted hydroxypropyl cellulose and mix well.

[0033] 4. Make soft materials with water, granulate with 24 mesh, dry at 60°C, and granulate with 40 mesh.

[0034] 5. Add magnesium stearate, mix well, and press into tablets.

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PUM

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Abstract

The invention relates to an oral tablet with tofisopam as an active ingredient, and a using method of the oral tablet. The oral tablet is an oral solid preparation prepared from the tofisopam and pharmaceutically acceptable auxiliary materials by a preparation technology. The tofisopam solid preparation disclosed by the invention is stable and controllable in quality, convenient to take, good in compliance and fewer in side effects. The preparation is mainly clinically applied to treatment of headache, heavy sensation of head, taediumvitae, tachycardia, the symptoms such as sweating caused by autonomic instability, head and neck injuries, menopausal troubles, anovarism and the like.

Description

technical field [0001] The invention relates to an oral tablet of tofisopam. It is an oral ordinary tablet, film-coated tablet, enteric-coated tablet, packaged chip, effervescent tablet, orally disintegrating tablet made of tofisopam and pharmaceutically acceptable excipients through preparation technology. The tofisopam oral tablet of the invention and its application quality are stable, controllable, safe and effective, and belong to the technical field of medicine. Background technique [0002] Tofisopam is an anti-anxiety drug developed by Mochida Corporation in Japan, which was launched in Japan in 1985. Tofisopam is a 2,3-benzodiazepine drug, which is similar in structure to 1,4-benzodiazepine drugs (such as diazepam). Tofisopam has selective anxiolytic effects, but does not have the sedative, anticonvulsant and muscle relaxant properties of general benzodiazepines. Compared with traditional benzodiazepines, the side effects of Somnia are rare and not obvious. In t...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/30A61K9/28A61K9/46A61K31/551A61P25/22A61P25/24A61P25/00A61P15/12
Inventor 不公告发明人
Owner FUKANGREN BIO PHARMA
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