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Pediatric domperidone suspension and preparation method thereof

A technology of domperidone and suspension, which is applied in the field of medicine and can solve the problems of bitterness and low drug dissolution rate of drugs

Active Publication Date: 2016-07-06
SHANDONG SBOND PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Aiming at the deficiencies of the prior art, the present invention provides a suspension of domperidone for children and a preparation method thereof. Through innovative selection of excipients, optimized ratio of excipients and innovative preparation process, the low dissolution rate of the drug and the bitterness of the drug are successfully solved. question

Method used

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  • Pediatric domperidone suspension and preparation method thereof
  • Pediatric domperidone suspension and preparation method thereof
  • Pediatric domperidone suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0233] Embodiment 1, a kind of preparation method of children's domperidone suspension

[0234] 1. A suspension of domperidone for children, made of the following raw materials in parts by mass:

[0235]

[0236] 2. The preparation method is as follows:

[0237] (1) Domperidone is pulverized and passed through a 150-mesh sieve to obtain particles with an average particle diameter of 28-32 μm for subsequent use;

[0238] (2) Pulverize the montmorillonite and pass through 100 meshes to obtain an average particle size of 12-16 μm for subsequent use;

[0239] (3) Take the domperidone of step (1) and the montmorillonite of step (2) according to the proportioning ratio, add 1 / 2 purified water of the total amount of water, and carry out ultrasonic treatment for 20 minutes under stirring; the ultrasonic frequency is 40KHz, continue to stir 1~2h, stand still for 2~3h, set aside;

[0240] (4) Weigh saccharin sodium, vanillin, glycerin, and sorbitol according to the proportion and ...

Embodiment 2

[0242] Embodiment 2, a kind of preparation method of children's domperidone suspension

[0243] 1. A suspension of domperidone for children, made of the following raw materials in parts by mass:

[0244]

[0245] 2. The preparation method is as follows:

[0246] (1) Domperidone is pulverized and passed through a 155-mesh sieve to obtain particles with an average particle diameter of 24-28 μm for subsequent use;

[0247] (2) Pulverize the montmorillonite and pass through 110 meshes to obtain an average particle size of 8-10 μm, which is set aside;

[0248] (3) Take the domperidone of step (1) and the montmorillonite of step (2) according to the proportioning ratio, add 1 / 2 purified water of the total water amount, and carry out ultrasonic treatment for 25 minutes under stirring; the ultrasonic frequency is 30KHz, continue to stir 1~2h, stand still for 2~3h, set aside;

[0249] (4) Weigh saccharin sodium, vanillin, glycerin, and sorbitol according to the proportion and mix...

Embodiment 3

[0251] Embodiment 3, a kind of preparation method of children's domperidone suspension

[0252] 1. A suspension of domperidone for children, made of the following raw materials in parts by mass:

[0253]

[0254]

[0255] 2. The preparation method is as follows:

[0256] (1) Domperidone is pulverized and passed through a 160-mesh sieve to obtain particles with an average particle diameter of 21-24 μm for subsequent use;

[0257] (2) Pulverize the montmorillonite and pass through 110 meshes to obtain an average particle size of 8-10 μm, which is set aside;

[0258] (3) Take the domperidone of step (1) and the montmorillonite of step (2) according to the proportioning ratio, add 1 / 2 purified water of the total amount of water, and carry out ultrasonic treatment for 10 minutes under stirring; the ultrasonic frequency is 45KHz, continue to stir 1~2h, stand still for 2~3h, set aside;

[0259] (4) Weigh saccharin sodium, vanillin, glycerin, and sorbitol according to the pro...

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Abstract

The invention discloses a pediatric domperidone suspension and a preparation method thereof. The suspension comprises domperidone, an antibacterial agent, a corrective, a suspending agent, a masking agent and a diluent, wherein the suspending agent and the masking agent both are montmorillonite, the average particle size of the montmorillonite is 8 to 27 [mu]m, and the dosage of the montmorillonite is 0.22% to 4.34% (w / w) of the total amount of the formula. According to the invention, the suspension is prepared by processes of preparing the domperidone with montmorillonite hydrogels, hydrogel microparticles with a rapid diffusion controlled drug release mechanism, a drug-containing suspension and the like, so that the problems of low drug dissolution rate, bitterness and the like are successfully solved to greatly improve the medication compliance and provide a good effect for functional dyspepsia of children.

Description

technical field [0001] The invention relates to a drug for gastrointestinal motility, in particular to a children's domperidone suspension and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Domperidone, the first peripheral dopamine receptor blocker, increases lower esophageal sphincter pressure and improves gastric emptying by increasing gastric emptying and promoting antrum-duodenal coordination. Upper gastrointestinal motility plays a key role in the pathogenesis of functional epigastric discomfort. [0003] Anorexia caused by insufficient gastric motility in children, also known as functional dyspepsia in children, refers to the long-term loss of appetite or lack of appetite in children due to lack of gastric motility. Anorexia affects children's growth and development, nutritional status, and intellectual development. Long-term anorexia can lead to malnutrition anemia, rickets, low immunity, and repeated respi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/454A61K47/02A61P1/14A61P1/04
CPCA61K9/0053A61K9/10A61K31/454A61K47/02
Inventor 乔敏袁武杰
Owner SHANDONG SBOND PHARMA
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