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Composition for improving stability of compound ibuprofen preparations and preparation method of composition

A technology of ibuprofen and a composition is applied in the field of compositions for improving the stability of compound ibuprofen preparations and the field of preparation thereof, which can solve problems such as potential safety hazards of clinical medication, and achieve extending the validity period of products, improving product quality, and reducing risks. Effect

Inactive Publication Date: 2015-07-08
铂镁医学临床研究(上海)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

through the original drug The detection of chlorpheniramine maleate degrades to about 4%, which brings hidden dangers to the safety of clinical medication

Method used

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  • Composition for improving stability of compound ibuprofen preparations and preparation method of composition
  • Composition for improving stability of compound ibuprofen preparations and preparation method of composition
  • Composition for improving stability of compound ibuprofen preparations and preparation method of composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1 The formula of protagonist and that amine tablet 1:

[0045]

[0046]

[0047] Concrete preparation process steps are as follows:

[0048] (a) Grinding phenylephrine hydrochloride through a 60-mesh sieve, then uniformly mixing it with glyceryl behenate at a weight ratio of 1:1, heating the mixture in a constant temperature oven at 80-90°C for 10-15 minutes, The mixture is melted, then cooled to room temperature, pulverized through a 40-mesh sieve, and set aside;

[0049] (b) Grind chlorpheniramine maleate through a 60-mesh sieve, then mix it with glyceryl behenate at a weight ratio of 1:1, and heat the mixture in a constant temperature oven at 80-90°C for 10-15 Minutes, the mixture is melted, then cooled to room temperature, pulverized through a 40 mesh sieve, and set aside;

[0050] (c) Pulverize the ibuprofen through a 60-mesh sieve, mix it evenly with pregelatinized starch, add 5% hydroxypropyl methylcellulose aqueous solution to make a soft mate...

Embodiment 2

[0052] Embodiment 2 The formula of protagonist and that amine tablet 2:

[0053]

[0054]

[0055] Concrete preparation process steps are as follows:

[0056] (a) Grinding phenylephrine hydrochloride through a 60-mesh sieve, then uniformly mixing it with glyceryl behenate at a weight ratio of 1:4, heating the mixture in a constant temperature oven at 80-90°C for 10-15 minutes, The mixture is melted, then cooled to room temperature, pulverized through a 40-mesh sieve, and set aside;

[0057] (b) Grind chlorpheniramine maleate through a 60-mesh sieve, then mix it evenly with glyceryl behenate at a weight ratio of 1:4, and heat the mixture in a constant temperature oven at 80-90°C for 10-15 Minutes, the mixture is melted, then cooled to room temperature, pulverized through a 40 mesh sieve, and set aside;

[0058] (c) Pulverize the ibuprofen through a 60-mesh sieve, mix it evenly with pregelatinized starch, add 5% hydroxypropyl methylcellulose aqueous solution to make a so...

Embodiment 3

[0063] Example 3 The formula of Buprorenalin Capsule 1:

[0064]

[0065] Concrete preparation process steps are as follows:

[0066] (a) Grinding phenylephrine hydrochloride through a 60-mesh sieve, then uniformly mixing it with glyceryl behenate at a weight ratio of 1:1, heating the mixture in a constant temperature oven at 80-90°C for 10-15 minutes, The mixture is melted, then cooled to room temperature, pulverized through a 40-mesh sieve, and set aside;

[0067] (b) Grind chlorpheniramine maleate through a 60-mesh sieve, then mix it with glyceryl behenate at a weight ratio of 1:1, and heat the mixture in a constant temperature oven at 80-90°C for 10-15 Minutes, the mixture is melted, then cooled to room temperature, pulverized through a 40 mesh sieve, and set aside;

[0068] (c) Crush the ibuprofen through a 60-mesh sieve, then mix it evenly with pregelatinized starch and starch, add 7% starch slurry to make a soft material, granulate with a 30-mesh sieve, dry at 55-6...

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Abstract

The invention discloses a composition for improving stability of compound ibuprofen preparations. The composition comprises the following components in parts by weight: 200 parts of ibuprofen, 10 parts of phenylephrine hydrochloride, 4 parts of chlorpheniramine maleate, 14-56 parts of glyceryl behenate and 50-800 parts of additives. The compound ibuprofen preparation composition can be directly used for preparing compound ibuprofen solid preparations such as tablets, capsules or granules or can be mixed with a proper quantity of additives to prepare the compound ibuprofen solid preparations such as tablets, capsules or granules by virtue of processes of tabletting, filling capsules or split charging. The compound ibuprofen preparation composition can be used for greatly improving the stability of ibuprofen, phenylephrine hydrochloride and chlorpheniramine maleate; the quality of products can be improved; the effective periods of the products can be prolonged; the risk of clinical medication is reduced.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a composition for improving the stability of compound ibuprofen preparations and a preparation method thereof. Background technique [0002] Buprorenalin Namin Tablets are used to relieve fever, headache, sore throat, sore limbs, joint pain, nasal congestion, runny nose, sneezing and other symptoms caused by common cold, influenza, acute rhinitis or acute sinusitis. Among them, ibuprofen is currently the only non-steroidal anti-inflammatory drug and children's antipyretic drug recommended by the US FDA for clinical use; Relieve nasal congestion, runny nose and other symptoms; chlorpheniramine maleate can shrink nasal mucosa blood vessels, reduce inflammatory exudation, relieve nasal congestion, runny nose, sneezing and other symptoms. The combination of the three can work together on various symptoms of the common cold, with small dosage, quick effect, good safety,...

Claims

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Application Information

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IPC IPC(8): A61K47/14A61K31/4402A61K31/192A61K31/137A61K9/20A61K9/48A61K9/14A61P11/00A61P11/02A61P29/00
Inventor 侯军旗
Owner 铂镁医学临床研究(上海)有限公司
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