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The preparation method of domperidone tablet

A technology for dipperidone tablets and domperidone, applied to non-active ingredient medical preparations, active ingredient-containing medical preparations, pharmaceutical formulas, etc., can solve problems such as not considering the friability of plain tablets, and achieve high production efficiency , fast dissolution rate, high tablet hardness

Active Publication Date: 2020-01-07
四川维奥制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the method of the present invention does not consider problems such as the friability of plain tablets during the preparation process.

Method used

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  • The preparation method of domperidone tablet
  • The preparation method of domperidone tablet

Examples

Experimental program
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Effect test

Embodiment 1

[0031] The preparation method of embodiment 1 domperidone sheet

[0032] (1) Ingredients: Clear the site for inspection and receive raw and auxiliary materials. Among them, the raw material is 4 parts of domperidone, and the auxiliary materials include 40 parts of lactose G200, 8 parts of pregelatinized starch, 5 parts of low-substituted hydroxypropyl cellulose, 2 parts of povidone K30, 0.3 parts of sodium lauryl sulfate, 0.1 parts of silicon dioxide, 1.2 parts of magnesium stearate;

[0033] (2) Granulation: with purified water, povidone K30 is mixed with the povidone K30 solution that the mass percent concentration is 20%, and the raw and auxiliary materials except magnesium stearate, povidone K30 and silicon dioxide are passed through Sieve and stir to obtain mixture 1, then slowly add povidone K30 solution and 8% purified water by mass of mixture 1, and stir evenly, sieve to make wet granules, dry, sieve and collect to obtain dry granules ;

[0034] (3) Blending: adding ...

Embodiment 2

[0036] The preparation method of embodiment 2 domperidone tablets

[0037] (1) Ingredients: Clear the site for inspection and receive raw and auxiliary materials. Among them, the raw materials are 8 parts of domperidone, and the auxiliary materials include 30 parts of lactose G200, 16 parts of pregelatinized starch, 1 part of low-substituted hydroxypropyl cellulose, 5 parts of povidone K30, 0.05 parts of sodium lauryl sulfate, 1.5 parts of silicon dioxide, 0.1 parts of magnesium stearate;

[0038] (2) Granulation: with purified water, povidone K30 is mixed with the povidone K30 solution that the mass percent concentration is 45%, and the raw and auxiliary materials except magnesium stearate, silicon dioxide and povidone K30 are passed through Sieve and stir to obtain mixture 1, then slowly add povidone K30 solution and purified water, the quality of purified water is 11% of the mass of mixture 1, stir evenly, sieve to make wet granules, dry, sieve and collect , to obtain dry ...

Embodiment 3

[0041] The preparation method of embodiment 3 domperidone tablets

[0042] (1) Ingredients: Clear the site for inspection and receive raw and auxiliary materials. Among them, the raw material is 6 parts of domperidone, and the auxiliary materials include 36 parts of lactose G200, 12 parts of pregelatinized starch, 3 parts of low-substituted hydroxypropyl cellulose, 3.6 parts of povidone K30, 0.12 parts of sodium lauryl sulfate, 0.6 parts of silicon dioxide, 0.48 parts of magnesium stearate;

[0043] (2) Granulation: with purified water, povidone K30 is mixed with the povidone K30 solution that mass percent concentration is 35%, will pass the raw and auxiliary materials except magnesium stearate, silicon dioxide and povidone K30 Sieve and stir to obtain mixture 1, then slowly add povidone K30 solution and purified water, the quality of purified water is 10% of the mass of mixture 1, stir evenly, sieve to make wet granules, dry, sieve and collect , to obtain dry particles;

[...

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Abstract

The invention provides a preparation method of domperidone tablets, comprising the following steps: (1) material preparation: performing site-clearing inspection, getting a raw material domperidone, and ingredients lactose G200, pregelatinized starch, low-substituted hydroxypropyl cellulose, povidone K30, lauryl sodium sulfate, silica and magnesium stearate; (2) pelleting: sieving and uniformly mixing raw material and ingredients except povidone K30, silica and magnesium stearate, then slowly adding a povidone K30 solution, uniformly stirring, and sieving to prepare wet particles, drying, sieving and collecting to obtain dry particles; (3) generally blending: respectively adding silica and magnesium stearate into the dry particles obtained in the step (2), to obtain generally mixed particles; and (4) tabletting, and the like. The method is high in production efficiency, and can enable the prepared domperidone tablets to be high in dissolving-out speed and relatively long in expirationdate while ensuring relatively high streptomycin hardness.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of domperidone tablets. Background technique [0002] Low gastric motility is a common symptom of modern people. Low gastric motility often leads to functional dyspepsia, gastroesophageal reflux and other diseases, which greatly affects people's quality of life. According to statistics, the incidence rate of gastric disease in my country is about 7% to 10%, and the number of patients is about 300 million people, ranking first in the world. Gastrointestinal drugs have always occupied a relatively large market share. Since Xi’an Janssen introduced the third-generation gastrodynamic drug-cisapride into the domestic market in 1993, the hospital market for gastrodynamic drugs has developed rapidly and has become an important drug for gastrointestinal diseases in China. clinical medication. [0003] Domperidone, developed by Belgian Janssen ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/32A61K47/20A61K31/454A61P1/14A61P1/04A61P1/08
CPCA61K9/2013A61K9/2027A61K31/454A61P1/04A61P1/08A61P1/14
Inventor 尹华国刘航张显坤李长岭董国张曼曼廖光丹
Owner 四川维奥制药有限公司
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