Domperidone tablet and preparation method thereof

A technology for dipperidone tablets and domperidone, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problem of unstable content uniformity of active ingredients and unfavorable products to exert their efficacy, etc. problems, to achieve consistent appearance and dissolution curve, excellent appearance, and excellent dissolution performance

Active Publication Date: 2021-01-05
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

[0010] However, the above-mentioned patent application only focused on the dissolution performance of domperidone tablets, and the content uniformity of the active ingredients was not stable, which was not conducive to the drug effect of the product

Method used

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  • Domperidone tablet and preparation method thereof
  • Domperidone tablet and preparation method thereof
  • Domperidone tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062]A domperidone tablet, in parts by weight, comprising the following components: 1 part of domperidone, 6 parts of lactose, 2 parts of pregelatinized starch, 0.5 parts of low-substituted hydroxypropyl cellulose, 0.6 parts of povidone K30, and dodecane 0.01 part of sodium sulphate, 0.1 part of silicon dioxide, 0.08 part of magnesium stearate.

[0063]The preparation process of the above-mentioned domperidone tablet includes the following steps:

[0064]1) Premix domperidone and the same amount of lactose (1 part) for 2 minutes to obtain mixture A;

[0065]2) Take the same amount of lactose as domperidone, crush it in a pulverizer, and pass through a 100-mesh sieve to obtain substance B;

[0066]3) The mixture A is crushed in a pulverizer and passed through a 100-mesh sieve 3 times to obtain a mixture C;

[0067]4) Crush substance B again in the pulverizer, pass through a 100-mesh sieve once, collect the sieved substance B (including the residual mixture C in the pulverizer cavity), after collec...

Embodiment 2

[0073]A domperidone tablet, calculated in parts by weight, comprising the following components: 1 part of domperidone, 10 parts of microcrystalline cellulose, 3.5 parts of starch, 0.8 parts of sodium carboxymethyl starch, 0.9 parts of polyethylene glycol (molecular weight 2000) , 0.0045 parts of sodium dodecyl sulfonate, 0.05 parts of talc, 0.13 parts of magnesium stearate.

[0074]The preparation process of the above-mentioned domperidone tablet includes the following steps:

[0075]1) Premix domperidone and the same amount of microcrystalline cellulose for 10 minutes to obtain mixture A;

[0076]2) Take another microcrystalline cellulose equivalent to domperidone, pulverize it in a pulverizer, and pass through a 60-mesh sieve to obtain substance B;

[0077]3) The mixture A is crushed in a pulverizer and passed through a 60-mesh sieve to obtain the mixture C;

[0078]4) The substance B is pulverized again in the pulverizer, and it passes through a 60-mesh sieve 5 times, and the sieved substance B...

Embodiment 3

[0084]A domperidone tablet, in parts by weight, comprising the following components: 1 part of domperidone, 3 parts of microcrystalline cellulose, 0.5 part of pregelatinized starch, 0.1 part of sodium carboxymethyl starch, 0.3 part of povidone K30, ten 0.02 parts of sodium dialkyl sulfonate, 0.15 parts of sodium stearyl fumarate, and 0.03 parts of magnesium stearate.

[0085]The preparation process of the above-mentioned domperidone tablet includes the following steps:

[0086]1) Premix domperidone and the same amount of microcrystalline cellulose for 5 minutes to obtain mixture A;

[0087]2) Take the same amount of microcrystalline cellulose as domperidone, pulverize it in a pulverizer, and pass through an 80-mesh sieve to obtain substance B;

[0088]3) The mixture A is pulverized in a pulverizer and passed through an 80-mesh sieve to obtain the mixture C;

[0089]4) The substance B is pulverized again in the pulverizer, and passed through an 80-mesh sieve three times, and the sieved substance B ...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and particularly relates to a domperidone tablet and a preparation method thereof. The domperidone tablet is prepared fromthe following components in parts by weight: 1 part of domperidone, 3 to 10 parts of diluent A, 0.5 to 3.5 parts of diluent B, 0.1 to 0.9 part of disintegrating agent, 0.3 to 1.0 part of adhesive, 0.004 to 0.02 part of solubilizer, 0.05 to 0.15 part of lubricant A and 0.03 to 0.13 part of lubricant B, wherein the lubricant A is at least one of silicon dioxide, sodium stearyl fumarate and talcum powder; the lubricant B is magnesium stearate. The domperidone tablet has the advantages of low main drug loss, high content uniformity, excellent dissolution performance and excellent appearance.

Description

Technical field[0001]The invention relates to the technical field of pharmaceutical preparations, in particular to a domperidone tablet and a preparation method thereof.Background technique[0002]Low gastric motility is a common symptom of modern people. Low gastric motility often leads to functional dyspepsia and gastroesophageal reflux, which greatly affects people's quality of life. Gastrointestinal drugs have always occupied a large market share, and the gastrodynamic drug market has developed rapidly and has become an important clinical drug for gastrointestinal diseases in China.[0003]Doperidone developed by Janssen Pharmaceuticals in Belgium, as a representative of the second generation of gastrodynamic drugs, is a synthetic benzimidazole derivative with a chemical name of 5-chloro-1-[1-[3-(2, 3-Dihydro-2-oxo-1H-benzimidazol-1-yl)propyl]piperidin-4-yl]-1,3-dihydro-2H-benzimidazol-2-one, the structural formula is as follows :[0004][0005]Domperidone is a strong peripheral dopami...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/04A61K47/02A61K47/26A61K47/38A61K31/454A61P1/14A61P1/04A61P1/08
CPCA61K9/2009A61K9/2013A61K9/2018A61K9/2054A61K9/2095A61K31/454A61P1/14A61P1/04A61P1/08
Inventor 吴庆陈国文杨华承于润丽代瑛唐小沁苏兰生红蕾董国刘航张显坤李长玲张曼曼王艳廖光丹尹华国谢宇
Owner 四川维奥制药有限公司
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