A kind of domperidone tablet and preparation method thereof

A technology of domperidone and diperidone tablets, 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 the effect of excellent appearance, low loss and excellent dissolution performance

Active Publication Date: 2022-03-11
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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  • A kind of domperidone tablet and preparation method thereof
  • A kind of domperidone tablet and preparation method thereof
  • A kind of domperidone tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0063] The preparation technology of above-mentioned domperidone sheet, comprises the steps:

[0064] 1) Premix domperidone with an equal amount of lactose (1 part) for 2 minutes to obtain mixture A;

[0065] 2) Separately take lactose equivalent to that of domperidone, pulverize it in a pulverizer, and pass through a 100-mesh sieve to obtain substance B;

[0066] 3) Pulverize the mixture A in a pulverizer and pass through a 100-mesh sieve for 3 times to obtain the mixture C;

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

Embodiment 2

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

[0074] The preparation technology of above-mentioned domperidone sheet, comprises the steps:

[0075] 1) Premixing domperidone and an equal amount of microcrystalline cellulose for 10 minutes to obtain mixture A;

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

[0077] 3) Pulverize mixture A in a pulverizer and pass through a 60-mesh sieve to obtain mixture C;

[0078] 4) Pulverize substance B again in a pulverizer, pass through a 60-mesh sieve five times, collect the sieved su...

Embodiment 3

[0084] A domperidone tablet, comprising the following components in parts by weight: 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 parts 0.02 part of sodium dialkylsulfonate, 0.15 part of sodium stearyl fumarate, and 0.03 part of magnesium stearate.

[0085] The preparation technology of above-mentioned domperidone sheet, comprises the steps:

[0086] 1) Premixing domperidone with an equal amount of microcrystalline cellulose for 5 minutes to obtain mixture A;

[0087] 2) Separately take microcrystalline cellulose equivalent to that of domperidone, pulverize it in a pulverizer, and pass through an 80-mesh sieve to obtain substance B;

[0088] 3) Pulverize mixture A in a pulverizer and pass through an 80-mesh sieve to obtain mixture C;

[0089] 4) Pulverize the substance B again in the pulverizer, pass through the 80-mesh sieve three times, collect the sie...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to a domperidone tablet and a preparation method thereof. The domperidone tablet comprises the following components in parts by weight: 1 part of domperidone, 3-10 parts of diluent A, and 0.5 parts of diluent B -3.5 parts, 0.1-0.9 parts of disintegrant, 0.3-1.0 parts of binder, 0.004-0.02 parts of solubilizer, 0.05-0.15 parts of lubricant A, 0.03-0.13 parts of lubricant B; At least one of silicon oxide, sodium stearyl fumarate and talc, and the lubricant B is magnesium stearate. The invention has the advantages of small loss of main ingredients, 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, gastroesophageal reflux and other diseases, which greatly affects people's quality of life. Gastrointestinal drugs have always occupied a relatively large market share, and the gastric motility drug market has developed rapidly, and has now become an important clinical drug for gastrointestinal diseases in China. [0003] Domperidone (Doperidone) developed by Janssen Pharmaceutical Company of Belgium is a representative of the second-generation gastric motility drug. It 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...

Claims

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Application Information

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Patent Type & Authority Patents(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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