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Domperidone suspension and preparation method thereof

A domperidone and suspension technology, which is used in pharmaceutical formulations, emulsion delivery, medical preparations with inactive ingredients, etc., can solve the problems of easy product agglomeration, affecting product quality, and poor redispersibility.

Active Publication Date: 2011-07-06
重庆健能医药开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This product has good stability and sweet taste, but in long-term storage, about 2 to 3 years, the product is easy to agglomerate, and the redispersibility is not good, which may affect the quality of the product

Method used

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  • Domperidone suspension and preparation method thereof
  • Domperidone suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] 1. Prescription:

[0019] Domperidone 1g

[0020] Sodium Carboxymethyl Cellulose 6g

[0021] Microcrystalline Cellulose 8g

[0022] Polysorbate-20 0.3ml

[0023] Sorbitol 80g

[0024] Methylparaben 1.5g

[0025] Propylparaben 0.1g

[0026] Sodium saccharin 0.1g

[0027] Add water to make up to 1000ml

[0028] 2. Process steps:

[0029] (1) Take sodium carboxymethyl cellulose in an appropriate amount of water, stir and dissolve to obtain solution I;

[0030] (2) Weigh methylparaben, propylparaben, sorbitol and sodium saccharin in an appropriate amount of water, stir and dissolve to obtain solution II;

[0031] (3) Take polysorbate-20, add domperidone and add a small amount of water to stir and moisten evenly to obtain suspension liquid III;

[0032] (4) Combine solutions I, II, and III and add microcrystalline cellulose for mixing, then add purified water to set the volume to the mark, stir and mix, pass through a colloid mill for 0.5h, and then transfer the me...

Embodiment 2

[0035] 1. Prescription:

[0036] Domperidone 1g

[0037] Sodium Carboxymethyl Cellulose 8g

[0038] Microcrystalline Cellulose 12g

[0039] Polysorbate-20 0.7ml

[0040] Sorbitol 120g

[0041] Methylparaben 2.0g

[0042] Propylparaben 0.3g

[0043] Sodium saccharin 0.4g

[0044] Add water to make up to 1000ml

[0045] 2. Process steps:

[0046] (1) Take sodium carboxymethyl cellulose in an appropriate amount of water, stir and dissolve to obtain solution I;

[0047] (2) Weigh methylparaben, propylparaben, sorbitol and sodium saccharin in an appropriate amount of water, stir and dissolve to obtain solution II;

[0048] (3) Take polysorbate-20, add domperidone and add a small amount of water to stir and moisten evenly to obtain suspension liquid III;

[0049] (4) Combine solutions I, II, and III and add microcrystalline cellulose for mixing, then add purified water to set the volume to the mark, stir and mix, pass through a colloid mill for 0.5h, and then transfer the ...

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Abstract

The invention discloses a domperidone suspension, and each 1000ml of the suspension comprises the following components: 1g of domperidone, 6g-8g of sodium carboxymethyl cellulose, 8g-12g of microcrystalline cellulose, 0.3ml-0.7ml of polysorbate, 80g-120g of sorbierite, 1.5g-2.0g of methylparaben, 0.1g-0.3g of propylparaben, 0.1g-0.4g of saccharine sodium salt and the balance of water. The suspension is good in stability and redispersibility, has sweet flavor, can be preserved for 5 years, and is free of agglomeration.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a gastrointestinal prokinetic drug, in particular to a domperidone suspension and a preparation method thereof. Background technique [0002] Domperidone is a gastric motility and antiemetic drug developed by Janson Company in Belgium. It is used for the treatment of functional, organic and infectious nausea, vomiting and non-ulcer dyspepsia. The drug was first launched in Belgium in 1978 and has been successively launched in Germany, Italy, Britain, Japan, France and other countries, and has been widely used in countries all over the world. [0003] Domperidone raw material is white or off-white powder; slightly soluble in ethanol, very slightly soluble in acetone, almost insoluble in water. [0004] Domperidone suspension is currently on the market in my country, and its prescription contains the following excipients: sodium carboxymethylcellulose, microcrystalline cel...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/454A61K47/38A61P1/08A61P1/14
Inventor 刘萍
Owner 重庆健能医药开发有限公司
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