Difenidol hydrochloride oral disintegrating tablet and prparation process thereof

An orally disintegrating tablet and preparation technology, applied in the field of orally disintegrating difenidol hydrochloride, can solve the problems of inconvenient use, poor compliance, and poor effect of patients, and achieve good promotion prospects, unique formula, and simple production process.

Inactive Publication Date: 2005-05-25
江西省药物研究所
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Ordinary tablets need to drink water and swallow to complete the medication process. This dosage form has poor compliance for some elderly people, children, and patients who have difficulty swallowing, and its use is restricted under some special conditions (such as lack of drinking water) or poor effect ( If it is used as anti-motion sickness prophylaxis, it needs to be increased by half an hour, and the effect of temporary medication will be poor)
Although injections take effect quickly, they must be assisted by medical staff, which is inconvenient for patients to use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0025] Implement 1 example

[0026] The drug active ingredient difenidol hydrochloride is used as the main drug, and other ingredients are used as auxiliary materials to prepare fast-disintegrating tablets. The formulation of the present invention consists of the following components in parts by weight:

[0027] a. Diphenidol hydrochloride 25g

[0028] b. Microcrystalline cellulose 12g

[0029] c. Cross-linked polyvinylpyrrolidone 8.4g

[0030] d. Citric acid 5.6g

[0031] e. Sodium bicarbonate 4g

[0032] f. Polyvinylpyrrolidone 1.2g

[0033] g. Stevioside 2.8g

[0034] h. Micropowder silica gel 0.4g

[0035] i. Magnesium stearate 0.4g

[0036] The dosage form can be produced by conventional tablet pharmaceutical equipment and prepared by pressing technology. The specific preparation method is as follows: grind stevioside and the main drug separately and pass through an 80-mesh sieve, mix stevioside and the main drug evenly; microcrystalline fiber Sodium bicarbonate, ...

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PUM

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Abstract

Diphenidol hydrochloride orally disintegrating tablets, including difenidol hydrochloride, solid dispersion carrier, filler, disintegrant, effervescent agent, flavoring agent, lubricant, etc. The present invention adopts the principle of effervescence and directly adds a disintegrant to the prescription to achieve the effect of rapid disintegration. The characteristics of the preparation are: the process is simple, and it can be directly compressed by conventional tablet pharmaceutical equipment; it is convenient to take, When taking the medicine, the medicine can be fully disintegrated without water in the mouth without a gritty feeling, especially suitable for some patients with dysphagia; the onset of effect is fast, the peak is reached early, and the disintegration time of the preparation is about It can be completed within 1-50 seconds, which is conducive to the dissolution and absorption of drugs and shortens the time to reach the peak blood drug.

Description

Technical field: [0001] The invention belongs to pharmaceutical preparations, and relates to an orally disintegrating tablet dosage form, in particular to a difenidol hydrochloride orally disintegrating tablet which is compressed by a direct tableting method and has quick-release effects. Background technique: [0002] The chemical name of difenidol hydrochloride is α, α-diphenyl-1-piperidine butanol hydrochloride, also known as difenidol, difenidol, diphenperidine, etc. Azines. This product has a strong antiemetic effect. It achieves anti-vertigo and antiemetic effects by improving the insufficiency of the cone-bottom artery, adjusting the vestibular and abnormal nerve impulses, inhibiting the vomiting center, and improving nystagmus. It is used for various diseases. Vertigo, vomiting (such as vertebrobasilar insufficiency, Meniere's disease, autonomic dysfunction, hypertension, hypotension, cervical vertigo, trauma or drug poisoning), vomiting after surgical anesthesia; m...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4453A61P1/08A61P9/02
Inventor 龚拥军曾文丽张悦晗庄妍周临
Owner 江西省药物研究所
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