A kind of ibuprofen pharmaceutical preparation composition and preparation method thereof

A technology of content and plasticizer, applied in the directions of drug combination, pharmaceutical formula, antipyretics, etc., can solve the problems of large soft capsule size, reduced efficacy, poor patient compliance, etc., to reduce the content of impurities and facilitate absorption , good stability

Active Publication Date: 2021-02-26
SHIJIAZHUANG PHARMA GRP NBP PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Pfizer of the United States prepared ibuprofen soft capsules (trade name: Advil), which was approved by the FDA in 1995, but did not disclose its prescription composition
Ibuprofen soft capsules, due to the inappropriate proportion of the ingredients in the contents, lead to large soft capsule size, high impurity content in the contents, poor patient compliance, and are also not conducive to human body absorption, reducing the curative effect; in addition, ibuprofen soft capsules The capsule skin has different composition ratios, which cause the components in the capsule skin to react with the active ingredients to form new impurities, such as ibuprofen glyceride (2 -(4-isobutyl)phenyl-6,7-dihydroxy-propyl propionate), this impurity cannot be hydrolyzed to regenerate ibuprofen in the environment of the body and affect the curative effect
[0006] In summary, prior art research on ibuprofen preparations can not meet the needs of clinical use

Method used

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  • A kind of ibuprofen pharmaceutical preparation composition and preparation method thereof
  • A kind of ibuprofen pharmaceutical preparation composition and preparation method thereof
  • A kind of ibuprofen pharmaceutical preparation composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0162] Embodiment 1: ibuprofen soft capsule

[0163] Contents prescription composition:

[0164]

[0165] Capsule composition: the same as Comparative Example 1

[0166] Preparation:

[0167] (1) Preparation of ibuprofen soft capsule contents

[0168] (1) Potassium hydroxide is dissolved in water to obtain potassium hydroxide solution;

[0169] (2) Add 1 / 2 of the ibuprofen to polyethylene glycol 600, stir (rotating speed is 15 revolutions / min) to obtain a suspension;

[0170] (3) Slowly drip 1 / 2 of the potassium hydroxide solution into the suspension of step (2), and stir (rotating at a speed of 15 rpm) until clarification; the addition time of the potassium hydroxide solution is 40 minutes;

[0171] (4) Add 1 / 2 of the ibuprofen to the solution in step (3), stir (rotating speed is 15 revolutions / min) to obtain a suspension;

[0172] (5) Slowly drop 1 / 2 of the potassium hydroxide solution into the suspension of step (4), stir (rotating at a speed of 15 rpm) to clarifica...

Embodiment 2

[0175] Embodiment 2: ibuprofen soft capsule

[0176] Contents prescription composition:

[0177]

[0178] Capsule skin composition: same as Comparative Example 1;

[0179] Preparation:

[0180] (1) Preparation of ibuprofen soft capsule contents

[0181] (1) Potassium hydroxide is dissolved in water to obtain potassium hydroxide solution;

[0182] (2) Add 1 / 2 of the ibuprofen to polyethylene glycol 600, stir (rotating at a speed of 18 revolutions / min) to obtain a suspension;

[0183] (3) Slowly drip 1 / 2 of the potassium hydroxide solution into the suspension of step (2), and stir (rotating at a speed of 18 rpm) until clarification; the addition time of the potassium hydroxide solution is 30 minutes;

[0184] (4) Add 1 / 2 ibuprofen to the solution in step (3), stir (rotating speed is 18 revolutions / min) to obtain a suspension;

[0185] (5) Slowly drop 1 / 2 of the potassium hydroxide solution into the suspension of step (4), stir (rotating at a speed of 15 rpm) to clarifica...

Embodiment 3

[0188] Embodiment 3: ibuprofen soft capsule

[0189] Contents prescription composition:

[0190]

[0191] Composition of the capsule:

[0192]

[0193] Preparation:

[0194] (1) Preparation of ibuprofen soft capsule contents

[0195] (1) Potassium hydroxide is dissolved in water to obtain potassium hydroxide solution;

[0196] (2) Add 1 / 2 of the ibuprofen to polyethylene glycol 600, stir (rotating at a speed of 18 revolutions / min) to obtain a suspension;

[0197] (3) Slowly drip 1 / 2 of the potassium hydroxide solution into the suspension of step (2), and stir (rotating at a speed of 18 rpm) until clarification; the addition time of the potassium hydroxide solution is 40 minutes;

[0198] (4) Add 1 / 2 ibuprofen to the solution in step (3), stir (rotating speed is 18 revolutions / min) to obtain a suspension;

[0199] (5) Slowly drop 1 / 2 of the potassium hydroxide solution into the suspension of step (4), stir (rotating at a speed of 15 rpm) to clarification, and the add...

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Abstract

The invention provides a pharmaceutical preparation composition of ibuprofen, comprising ibuprofen, polyethylene glycol, cosolvent potassium hydroxide or sodium hydroxide and water, which can be prepared into soft capsules with stable quality and good safety. It has the same efficacy (bioequivalence) as the original Advil.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation composition containing ibuprofen and a preparation method thereof. Background technique [0002] Ibuprofen is currently one of the most widely used non-steroidal anti-inflammatory drugs clinically. It has significant antipyretic, analgesic and anti-inflammatory effects. Almost insoluble; easily soluble in sodium hydroxide or sodium carbonate test solution. Its molecular formula: C 13 h 18 o 2 , molecular weight: 206.28, the structural formula is as follows: [0003] [0004] Ibuprofen belongs to the class II drug of the biopharmaceutical classification system (BCS), which has low solubility and high biofilm permeability (C=21 μg / mL, log P=3.97). Currently, ibuprofen preparations are mainly administered orally. Medicines, the products already on the market in China include Ibuprofen Sustained-release Capsules, Ibuprofen Tablets, Ibuprofen ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K47/10A61K47/02A61K31/192A61P29/00
CPCA61K9/4808A61K9/4825A61K9/4858A61K9/4866A61K31/192A61P29/00
Inventor 焦魁良田晓月李园园齐军彩张琪
Owner SHIJIAZHUANG PHARMA GRP NBP PHARMA CO LTD
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