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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 of inactive ingredients, and digestive system, etc., can solve problems such as non-compliance with product standards, prolonged product dispersion time, etc., and achieve short disintegration time. , The effect of rapid drug dissolution and convenient administration

Inactive Publication Date: 2015-01-07
GUANGZHOU WEIXI PHARMA
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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] Sodium lauryl sulfate, povidone K30, and low-substituted hydroxypropyl cellulose were selected as disintegrants, and the dosage was 18%, half of which was added before and after granulation, and then the appearance and uniformity of the tablets were detected, and the results See 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 lauryl sulfate, the concentration of the binder was investigated, with dispersion uniformity as the main index, and tablet appearance and compressibility as the secondary Indicators for selecting 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] Take the prescribed amount of itopride hydrochloride, microcrystalline cellulose, lactose, povidone K30, sodium lauryl sulfate, and Tween 80, mix and sieve evenly, and mix with 60mL of 1% hydroxyethylcellulose aqueous solution (Concentration unit is g / mL, that is, 1g hydroxyethyl cellulose is dissolved in 100mL water, the same below) to make soft materials, granulate with 20-mesh nylon sieve, dry at 70°C for 2 hours, granulate with 24-mesh nylon sieve, and then add 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 disintegrating agent, wherein the disintegrating agent is povidone. According to the oral preparation, the problems that the appearance of tablets is rough, the tablets are easily broken, the tablets with rough appearance are easily moisturized and the colors of the tablets are easily changed in areas where the temperature is relatively low in winter are overcome. The oral preparation is short in disintegration time, high in dispersion uniformity, high in medicine dissolution speed, high in absorption and high in bioavailability, is convenient and flexible to orally take and has good taste; moreover, the medication compliance of patients 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): A61K9/20A61K31/166A61K47/32A61K47/38A61P1/14A61P1/08A61P1/00
Inventor 李伟
Owner GUANGZHOU WEIXI PHARMA
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