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Domperidone tablet and preparation process thereof

A perperidone tablet and a technology for a preparation process, which are applied in the directions of medical preparations without active ingredients, medical preparations containing active ingredients, and pill delivery, etc., can solve the problem of long preparation cycle, simple preparation process, and increased gastrointestinal irritation. problems such as properties, to achieve the effect of easy industrialized large-scale production and simple preparation process

Active Publication Date: 2014-11-05
广东人人康药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But this invention also has the following defects: (1) in order to make domperidone dissolve completely in the solvent, this invention has relied on the method for adding acidic substance, because domperidone molecule contains lactam structure, it is easy to hydrolyze, and the adding of acid and alkali will lead to the (2) In order to make the drug particles better dispersed, poloxamer, Tween, polyoxyethylene castor oil, sucrose ester and polyoxyl 40 stearate were added in the preparation process Surfactants such as esters can increase the irritation to the gastrointestinal tract; (3) the invention has complex processes, many auxiliary materials, and long preparation cycle, which is not conducive to reducing costs
[0012] Through careful retrieval of domestic and foreign literature, it is found that the prior art fails to provide a domperidone preparation with good dissolution rate and simple preparation process

Method used

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  • Domperidone tablet and preparation process thereof
  • Domperidone tablet and preparation process thereof
  • Domperidone tablet and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035]

[0036] Preparation Process:

[0037] (1) Dissolve domperidone in 150 mL of ethanol, add lactose, disperse, stir evenly, and dry under reduced pressure at 50°C to remove ethanol. With the volatilization of ethanol, domperidone slowly precipitates and adsorbs on the surface of lactose to obtain a drug-containing adsorbate;

[0038] (2) Add the tert-butanol suspension of polacrilin potassium IRP-88 to the above-mentioned drug-containing adsorbate, stir evenly, remove tert-butanol by volatilization under reduced pressure at 70°C, and settle the drug-containing adsorbate of domperidone and lactose on On the surface of Polacrilin Potassium IRP-88, drug-containing solid deposits were obtained;

[0039] (3) Mix the drug-containing solid deposit with sodium stearate fumarate evenly, and press into tablets.

Embodiment 2

[0041]

[0042]

[0043] Preparation Process:

[0044] (1) Dissolve domperidone in 100 mL of ethanol, add lactose to disperse, stir evenly, and dry under reduced pressure at 55°C to remove ethanol. With the volatilization of ethanol, domperidone slowly precipitates and adsorbs on the surface of lactose to obtain a drug-containing adsorbate;

[0045] (2) Add the tert-butanol suspension of polacrilin potassium IRP-88 to the above-mentioned drug-containing adsorbate, stir evenly, evaporate the tert-butanol under reduced pressure at 74°C, and settle the drug-containing adsorbate of domperidone and lactose on On the surface of Polacrilin Potassium IRP-88, drug-containing solid deposits were obtained;

[0046] (3) Mix the drug-containing solid deposit with magnesium stearate evenly, and press into tablets.

Embodiment 3

[0048]

[0049] Preparation Process:

[0050] (1) Dissolve domperidone in 120 mL of ethanol, add lactose to disperse, stir evenly, and dry under reduced pressure at 50°C to remove ethanol. With the volatilization of ethanol, domperidone slowly precipitates and adsorbs on the surface of lactose to obtain a drug-containing adsorbate;

[0051] (2) Add the tert-butanol suspension of polacrilin potassium IRP-88 to the above-mentioned drug-containing adsorbate, stir evenly, remove tert-butanol by volatilization under reduced pressure at 70°C, and settle the drug-containing adsorbate of domperidone and lactose on On the surface of Polacrilin Potassium IRP-88, drug-containing solid deposits were obtained;

[0052] (3) Mix the drug-containing solid deposit with magnesium stearate evenly, and press into tablets.

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PUM

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Abstract

The invention discloses a domperidone tablet and a preparation process thereof. The preparation process comprises the following steps: dissolving domperidone in alcohol, adding hydrophilic auxiliary materials, dispersing, drying under reduced pressure to remove alcohol, adding tertiary butanol suspension of polacrilin potassium, volatilizing to remove tertiary butanol to obtain drug-containing solid sediment; and uniformly mixing with other pharmaceutically acceptable auxiliary materials and tabletting. The domperidone tablet disclosed by the invention can be dissolved out quickly; and the preparation process is simple and suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a tablet containing domperidone and a preparation process thereof. Background technique [0002] Domperidone is a drug for digestive system diseases developed by the Belgian Janssen Pharmaceutical Company. The chemical name is 5-chloro-1-[1-[3-(2,3-dihydro-2-oxo-1H-benzimidazole-1- Base) propyl] piperidin-4-yl] -1,3-dihydro-2H-benzimidazol-2-one, the structural formula is as follows: [0003] [0004] Domperidone is a dopamine receptor antagonist with anti-emetic effect, and it is difficult to enter the brain through the blood-brain barrier. Domperidone acts on the chemoreceptor trigger area outside the blood-brain barrier, so it hardly acts on the central nervous system; domperidone selectively blocks dopamine 2 (DA2) receptors and mainly acts on the peripheral nervous system. Since DA2 receptors are also the main receptors in the gastrointes...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/454A61K47/26A61K47/32A61P1/08A61P1/04
Inventor 孙丽华
Owner 广东人人康药业有限公司
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