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Itopride hydrochloride oral preparation

A technology for itopride hydrochloride and oral preparations, which is applied in the directions of pill delivery, medical preparations with inactive ingredients, and digestive systems, can solve problems such as non-compliance with product standards, prolonged product dispersion time, and short disintegration time. , The effect of rapid drug dissolution and improved compliance

Inactive Publication Date: 2014-10-29
LIVZON GROUP LIVZON PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the pressure can be adjusted to make one side smooth and clean, the result is that the dispersion time of the product is prolonged or even does not meet the product standard requirements

Method used

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  • Itopride hydrochloride oral preparation
  • Itopride hydrochloride oral preparation
  • Itopride hydrochloride oral preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1. The selection of disintegrating agent

[0019] Select sodium carboxymethyl starch, povidone K30, and low-substituted hydroxypropyl cellulose as disintegrants, the dosage is 18%, add half of each before granulation and after granulation, and then detect the appearance and uniformity of the tablets, the results are shown in Table 1.

[0020] Table 1. Preliminary selection of disintegrants

[0021]

[0022] Composition C's appearance, color change and dispersion uniformity after low-temperature storage all meet the requirements, and it is a better solution.

Embodiment 2

[0023] Example 2. Selection of Adhesive

[0024] Based on the selection of filler microcrystalline cellulose, disintegrant povidone K30, and sodium carboxymethyl starch, the concentration of the binder was investigated, with dispersion uniformity as the main index and tablet appearance and compressibility as the secondary index. Choose the best prescription. The results are shown in Table 2.

[0025] Table 2. Choice of Binder Concentration

[0026]

[0027] Note: Measuring method for dispersion uniformity (s): Take 2 tablets of the test product, place in 100ml water at 20°C±1°C, shake, and record the total disintegration time.

[0028] It can be seen from Table 2 that considering the uniformity of tablet dispersion, appearance and compressibility, the most preferred 2% aqueous solution of hydroxyethyl cellulose is the binder.

Embodiment 3

[0029] Embodiment 3. The preparation of itopride hydrochloride oral preparation A

[0030] Prescription:

[0031]

[0032] Get the itopride hydrochloride, microcrystalline cellulose, lactose, povidone K30 and sodium carboxymethyl starch, Tween 80 mixing and sieving of prescription quantity and mix evenly, with 1% hydroxyethyl cellulose aqueous solution of 60mL ( The concentration unit is g / mL, that is, 1g of hydroxyethyl cellulose is dissolved in 100mL of water, the same below), made of soft material, granulated with a 20-mesh nylon sieve, dried at 70°C for 2 hours, granulated with a 24-mesh nylon sieve, and then added with micropowder silica gel and , determine the content, compress into tablets, and pack after passing the inspection.

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PUM

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Abstract

The invention discloses an itopride hydrochloride oral preparation. The oral preparation comprises 15-20 percent by weight of itopride hydrochloride and 10-30 percent by weight of a disintegrating agent, wherein the disintegrating agent is povidone. The oral preparation is used for overcoming the problems that a tablet is rough in appearance and easy to fracture, the tablet which is rough in appearance easily absorbs moisture and the color is changed in regions at low air temperature in winter and the like, is short in disintegrating time, good in dispersion uniformity, rapid in medicine dissolution, rapid in absorption, high in bioavailability, convenient and flexible to take and also good in taste and has the advantage that the compliance of patients for taking the medicine is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, in particular, the invention relates to a preparation method of an oral preparation of Itopride Hydrochloride (Itopride Hydrochloride). Background technique [0002] Itopride Hydrochloride is a methoxybenzamide drug, which is N-[4-[2-(dimethylamino)ethoxy]benzyl]-3,4-dimethoxybenzene The hydrochloride of formamide has the following structural formula: [0003] [0004] The raw material drug of itopride hydrochloride was developed by Hokuriku Pharmaceutical Co., Ltd., Japan, and has obtained patent rights in Japan and Europe. From a pharmacological point of view, itopride hydrochloride increases the release of acetylcholine through the antagonism of dopamine D2 receptors, and at the same time inhibits the decomposition of released acetylcholine through the inhibition of acetylcholinease, thereby enhancing the motility of the stomach and duodenum. Therefore, it is currently mainly used for va...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/32A61K31/166A61P1/14A61P1/08
Inventor 黄伟兴郭国岭徐晓陈大成钟贞李月颖吴婷婷
Owner LIVZON GROUP LIVZON PHARMA FACTORY
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