Pediatric paracetamol oral solution formula and preparation method thereof

A technology for oral solution and pediatric paracetamol, which is used in pharmaceutical formulations, drug combinations, and medical preparations containing active ingredients, etc., can solve problems such as different tastes, affect clinical application effects, etc. Effect

Active Publication Date: 2012-10-31
岳阳新华达制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the granules need to be taken with warm boiled water. Children will have a huge resistance to taking the medicine itself during the cold period, which will affect the clinical application effect.
Moreover, when the granules are mixed with water, the taste is often different due to the difference in the amount of water added.
Compared with granules, gels also have the above-mentioned disadvantages

Method used

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  • Pediatric paracetamol oral solution formula and preparation method thereof
  • Pediatric paracetamol oral solution formula and preparation method thereof
  • Pediatric paracetamol oral solution formula and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0109] The feeding amount is 12.5g of paracetamol, 0.5g of artificial bezoar and 0.05g of chlorpheniramine maleate, 7ml (7.34g) of glacial acetic acid, and 2g of potassium sorbate.

[0110] 1) Use 7ml of glacial acetic acid to completely dissolve 0.5g of artificial bezoar (normal temperature is enough, or it can be heated and dissolved at 60°C to 80°C), stir well for 30 minutes to 1 hour; stand still; filter with 0.45 and 0.22 microns Membrane secondary filtration, to obtain a clear yellow or light yellow solution.

[0111] 2) Add an appropriate amount of purified water into the batching tank, heat to a suitable temperature, add 12.5 g of acetaminophen in a feeding amount, and stir until fully dissolved.

[0112] 3) Add 0.05 g of chlorpheniramine maleate in a feeding amount into the batching tank that has completely dissolved paracetamol, stir well, and cool to room temperature.

[0113] 4) Add the clarified solution obtained in 1) into the batching tank, stir well, and after...

Embodiment 2

[0116] Feeding amount is paracetamol 12.5kg, artificial bezoar 0.5kg and chlorpheniramine maleate 0.05kg, glacial acetic acid 7L (7.34kg), potassium sorbate 2kg.

[0117] 1) Use 7L of glacial acetic acid to completely dissolve 0.5Kg of artificial bezoar (normal temperature is enough, or it can be heated and dissolved at 60°C to 80°C), stir well for 30 minutes to 1 hour; stand still; filter with 0.45 and 0.22 microns Membrane secondary filtration, to obtain a clear yellow or light yellow solution.

[0118] 2) Add an appropriate amount of purified water into the batching tank, heat to a suitable temperature, add 12.5Kg of acetaminophen in a feeding amount, and stir until fully dissolved.

[0119] 3) Add 0.05Kg of chlorpheniramine maleate in the batching tank that has completely dissolved paracetamol, fully stir, and cool to room temperature.

[0120] 4) Add the clarified solution obtained in 1) to the batching tank, stir well, and then add 2Kg of preservative potassium sorbate ...

Embodiment 3

[0123] Feeding amount is paracetamol 125kg, artificial bezoar 5kg and chlorpheniramine maleate 0.5kg, glacial acetic acid 70L (73.4kg), potassium sorbate 20kg.

[0124] 1) Use 70L of glacial acetic acid to completely dissolve 5Kg of artificial bezoar (normal temperature is enough, or it can be dissolved by heating at 60°C to 80°C), stir well for 30 minutes to 1 hour; stand still; use 0.45 and 0.2 micron filter membranes After secondary filtration, a clear yellow or light yellow solution was obtained.

[0125] 2) Add an appropriate amount of purified water into the batching tank, heat to a suitable temperature, add 125Kg of acetaminophen in a feeding amount, and stir until fully dissolved.

[0126] 3) Add 0.5Kg of chlorpheniramine maleate in the batching tank that has completely dissolved paracetamol, fully stir, and cool to room temperature.

[0127]4) Add the clarified solution obtained in 1) into the batching tank, stir well, and then add 20Kg of preservative potassium sorb...

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Abstract

The invention relates to a pediatric paracetamol oral solution formula and a preparation method thereof, and oral solution thereof is a compound preparation which mainly comprises acetaminophen, artificial bezoar, chlorpheniramine maleate and glacial acetic acid or citric acid. The key of the preparation method is to use the glacial acetic acid or the citric acid to dissolve the artificial bezoar, thereby improving the solubility of cholic acid which is a main active ingredient in the artificial bezoar from 77% by solid particles to above 95%, further greatly improving the human bioavailability of the cholic acid.

Description

technical field [0001] The present invention relates to an oral solution pharmaceutical preparation prepared by taking paracetamol, artificial bezoar, chlorpheniramine maleate and glacial acetic acid (or citric acid) as effective components as four kinds of pharmaceutical raw materials and auxiliary materials, and a preparation method thereof . In particular, it relates to a preparation method for preparing an oral solution of infantile paracetamol and huangpheniramine by using acetaminophen, artificial bezoar, chlorpheniramine maleate and glacial acetic acid (or citric acid). Background technique [0002] As we all know, colds are the most common diseases of human beings, and there are countless medicines for treating colds all over the world. As a large country with a population of 1.3 billion, our country has a huge cold medicine market, and our country has a traditional habit of using traditional Chinese medicine. There are more types of Chinese medicine, Western medici...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K35/413A61K31/167A61K31/19A61K31/194A61K31/4402A61P29/00
Inventor 随裕敏王湘源张全超汪芳
Owner 岳阳新华达制药有限公司
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