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Ibuprofen granules and preparation method thereof

A technology of granules and fillers, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. It is easy to deliquescence and inconvenient for children to use medicine, so as to achieve the effect of being suitable for industrial production, improving taste and pungent odor, and improving medication compliance.

Active Publication Date: 2015-05-13
HAINAN HULUWA PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The Chinese patent application with publication number CN101390844A discloses a kind of arginine ibuprofen tablet and preparation method thereof. Inconvenience, especially for children with medication inconvenience
[0004] The Chinese patent application with application number 200310108031.0 discloses a method for preparing granules containing ibuprofen arginine composition, in which a coating step is used to overcome the shortcoming of ibuprofen arginine which is easy to absorb moisture, and to cover up the drug itself irritating smell, but more than the general granule coating steps production cycle is long, high cost

Method used

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  • Ibuprofen granules and preparation method thereof
  • Ibuprofen granules and preparation method thereof
  • Ibuprofen granules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Pass the ibuprofen through a 100-mesh sieve, crush the sucrose, hypromellose K4M, sodium cyclamate and stevioside and pass through a 80-mesh sieve for later use.

[0036] Weigh the raw materials of the following prescription quantities:

[0037]

[0038] (1) Dissolve 6.1kg sucrose and 6.1kg sodium cyclamate in 100kg boiling water, stir well, and be mixed with filler aqueous solution; Hypromellose K4M is dissolved in 50% (volume percentage content) ethanol aqueous solution, stir Evenly, prepare 4.5 kg of 1% hypromellose K4M 50% ethanol aqueous solution, and set aside;

[0039] (2) Get ibuprofen 1.70kg and join in the coating granulator, start the main engine, set the rotating speed as 110 rev / min, spray the filler aqueous solution and 1.5kg 1% hypromellose of step (1) gained simultaneously K4M50% ethanol aqueous solution, peristaltic pump speed 15 rpm, after the granulator is dust-free, open the machine cover to observe and slow down the spray speed to 10 rpm, until ...

Embodiment 2

[0045] Pass the ibuprofen through a 100-mesh sieve, crush sucrose, polyvinylpyrrolidone, etc., and pass through an 80-mesh sieve for later use.

[0046] Weigh the raw materials of the following prescription quantities:

[0047]

[0048] (1) Dissolve 5.1kg of sucrose and 10.1kg of sodium cyclamate in boiling water, stir evenly, and prepare an aqueous filler solution; dissolve polyvinylpyrrolidone in 50% ethanol aqueous solution, stir evenly, and prepare 3% polyvinylpyrrolidone 5.1kg of 50% ethanol aqueous solution, for later use;

[0049](2) Get 2.50kg of ibuprofen and add it to the coating granulator, start the main engine, set the rotating speed to be 110 rpm, spray the aqueous filler solution and polyvinylpyrrolidine ethanol aqueous solution obtained in step (1) simultaneously, and the rotating speed of the peristaltic pump 15 rpm, after the granulator is free of dust, open the machine cover to observe and slow down the spray speed to 10 rpm, until the masterbatch is pro...

Embodiment 3

[0055] The ibuprofen is passed through a 100-mesh sieve, and the sucrose, polyvinylpyrrolidone, etc. are crushed and passed through a 80-mesh sieve for later use.

[0056] Weigh the raw materials of the following prescription quantities:

[0057]

[0058] (1) 10.1kg sucrose and 5.1kg sodium cyclamate were dissolved in boiling water, stirred evenly, and dissolved to be prepared as filler aqueous solution; polyvinylpyrrolidone was dissolved in ethanol aqueous solution and stirred uniformly, and 5.7kg of polyvinylpyrrolidone aqueous solution was prepared, spare;

[0059] (2) Get 3.50 kg of ibuprofen and add it to the coating granulator, start the main engine, set the rotating speed at 110 rpm, spray the aqueous filler solution obtained in step (1) and the ethanol aqueous solution of polyvinylpyrrolidone at the same time, and the rotating speed of the peristaltic pump is 15 After the granulator is clean, open the cover to observe and slow down the spray speed to 10 rpm until t...

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Abstract

The invention discloses ibuprofen granules which are prepared from the following raw materials in parts by weight: 1 part of ibuprofen, 1-100 parts of a filling agent, 1-20 parts of an adhesive, 0.2-10 parts of a thickening agent and 0.1-10 parts of a flavoring agent. The granules are rapidly dissolved in water to form clarified and transparent solution with good taste and are convenient to take, low in content of related substances and high in bioavailability. The invention also discloses a method for preparing the ibuprofen granules. The preparation method is easy to operate, does not need any special equipment and is suitable for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to ibuprofen granules and a preparation method thereof. Background technique [0002] Ibuprofen, chemical name: 2-methyl-4-(2-methylpropyl) phenylacetic acid, IUPAC name: 2-(4-isobutylphenyl) propanoic acid, CAS No.15687-27-1, molecular formula C 13 h 18 o 2 , with a molecular weight of 206.28, is a non-steroidal anti-inflammatory drug (NSAID). It is the first profen drug used clinically and is still widely used in the world. It is recognized as one of the safest drugs in non-steroidal anti-inflammatory drugs. 1. It has analgesic, anti-inflammatory and antipyretic effects. Its mechanism of action is to reduce the synthesis of prostaglandins by inhibiting cyclooxygenase, thereby reducing tissue congestion and swelling caused by prostaglandins, and reducing the sensitivity of peripheral nerve pain. Sex, and play an antipyretic effect through the hypothalamic thermoregula...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/192A61K47/26A61K47/20A61K47/38A61K47/32A61K47/12
Inventor 刘景萍刘全国陈克领林文君
Owner HAINAN HULUWA PHARMA GRP CO LTD
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