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A kind of ibuprofen taste-masking dry suspension for children and preparation method thereof

A dry suspension and children's technology, which is applied in the field of ibuprofen taste-masked dry suspension for children and its preparation, can solve the problem that it is difficult to meet the clinical treatment needs of infants and children with acute fever, and the individualized difference in antipyretic time is large. , children's poor medication compliance and other problems, to achieve the effect of improving medication compliance, improving physical stability, and improving pungency

Active Publication Date: 2022-04-05
上海金韶林医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that when the existing ibuprofen oral preparations are used for the treatment of acute fever in children, although the antipyretic effect is significant, the antipyretic speed is too slow, and the individual differences in antipyretic time are large, which is difficult to meet the clinical requirements of acute fever in infants and children. treatment needs
In addition, when the existing ibuprofen granules or suspensions are taken orally, the medicines in the dissolved form often produce a spicy feeling, and children's medication compliance is poor

Method used

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  • A kind of ibuprofen taste-masking dry suspension for children and preparation method thereof
  • A kind of ibuprofen taste-masking dry suspension for children and preparation method thereof
  • A kind of ibuprofen taste-masking dry suspension for children and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The present embodiment prepares 100g ibuprofen taste-masking dry suspension preparation for children, which is as follows in terms of the mass percentage of each material component:

[0030]Ibuprofen: 5%; Acrylic No. IV: 85%; Gum Arabic: 1%; Sucrose: 2%;

[0031] Poloxamer 188: 3%; Sodium Citrate: 3%; Stevioside: 0.5%

[0032] Preparation method: (1) Grind the prescribed amount of ibuprofen, acrylic resin No. IV, gum arabic, lactose, poloxamer 188, sodium citrate, and orange flavor, and pass through a 40-mesh sieve.

[0033] (2) Mix the ibuprofen and acrylic resin IV in the step (1) uniformly according to the above mass ratio to obtain a uniform mixture.

[0034] (3) The temperature of the hot-melt extruder is set to 70° C., and the rotation speed is 10 rpm. When the temperature and rotating speed rise to the set value, put the mixture prepared in step (2) into the material hopper of hot-melt extrusion, collect the extrudate at the material outlet of the hot-melt extr...

Embodiment 2

[0038] The present embodiment prepares 100g ibuprofen taste-masking dry suspension for children, which is as follows in terms of the mass percentage of each material component:

[0039] Ibuprofen: 5%; Acrylic No. IV: 85%; Gum Arabic: 1%; Lactose: 2%;

[0040] Poloxamer 188: 3%; Sodium Citrate: 3%; Orange Flavor: 1.0%

[0041] Preparation method: (1) Grind the prescribed amount of ibuprofen, acrylic resin No. IV, gum arabic, lactose, poloxamer 188, sodium citrate, and orange flavor, and pass through a 60-mesh sieve.

[0042] (2) Dissolve ibuprofen and acrylic resin No. IV in ethanol to obtain a uniform solution.

[0043] (3) Spray-dry the solution obtained in step (2), and the operating parameters are as follows: inlet air temperature 40°C, spray pressure 100KPa, outlet air temperature 40°C, after spray drying, maintain for 10 minutes for secondary drying. The ibuprofen-polymer carrier solid dispersion is obtained.

[0044] (4) Mix the dry granules obtained in step (3) with ...

Embodiment 3

[0046] The present embodiment prepares 100g ibuprofen taste-masking dry suspension for children, which is as follows in terms of the mass percentage of each material component:

[0047] Ibuprofen: 5%; Acrylic resin No. IV: 85%; Gum Arabic: 1%; Dextrin: 2%;

[0048] Poloxamer 188: 3%; Sodium Citrate: 3%; Orange Flavor: 0.5%

[0049] Preparation method: (1) Grind the prescribed amount of ibuprofen, acrylic resin No. IV, gum arabic, lactose, poloxamer 188, sodium citrate, and orange flavor, and pass through a 100-mesh sieve.

[0050] (2) The ibuprofen in the step (1) and the acrylic resin No. IV are mixed uniformly according to the above mass ratio to form a uniform mixture.

[0051] (3) heating and melting the homogeneous material obtained in step (2) to obtain a molten liquid.

[0052] (4) Spray and freeze the molten liquid obtained in step (3), enter air temperature at -5°C, spray speed at 2mL / min, and spray pressure at 100KPa to obtain the ibuprofen-polymer carrier solid di...

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Abstract

The invention discloses an ibuprofen taste-masking dry suspension for children and a preparation method thereof, comprising ibuprofen solid dispersion and pharmaceutically acceptable adjuvants, the ibuprofen solid dispersion is composed of ibuprofen and Composition of polymer carrier; pharmaceutically acceptable adjuvant is suspending agent, wetting agent, flocculant, filler, flavoring agent; wherein, in the mass percentage of each component in the ibuprofen taste-masking dry suspension, The ibuprofen is 1% to 25%, the polymer carrier is 58% to 95%, the suspending agent is 1% to 1.5%, and the wetting agent is 2% to 5%. The flocculant is 0.5%-3%, the filler is 2%-9%, and the corrective agent is 0.5%-1%. The present invention uses stomach-soluble polymer materials and water-soluble polymer materials as carriers, and disperses ibuprofen in the polymer carrier material in the form of a single molecule. Heat can significantly reduce the individual differences in the onset time of children or infants.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a taste-masked ibuprofen dry suspension for children and a preparation method thereof. Background technique [0002] Acute fever is a common clinical disease and frequently-occurring disease in children. When acute fever symptoms appear, the child's body temperature can reach 39-40°C. If the fever is not relieved in time, it can cause febrile convulsions. The nervous system is permanently damaged and life-threatening in children. Ibuprofen (α-methyl-4-(2-methylpropyl) phenylacetic acid), also known as ibuprofen (IBP), is commonly used in the treatment of acute fever in children, infants with acute fever and After oral administration of ibuprofen to children, the body temperature drops significantly within 1-2 hours, and the fever-reducing effect can be maintained for 6-8 hours. Ibuprofen has few oral adverse reactions and is relatively safe for children. It is the fir...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K31/192A61P29/00
CPCA61P29/00A61K9/146A61K31/192
Inventor 杨子毅左殷林霞
Owner 上海金韶林医药技术有限公司
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