Ibuprofen and phenylephrine hydrochloride-containing double-layer medicinal composition and preparation method thereof

A technology of phenylephrine hydrochloride and its composition, which is applied in the field of pharmaceutical preparations and can solve the problems of the preparation method of the ibuprofen-phenylephrine hydrochloride double-layer medicinal composition without patents and literature reports.

Inactive Publication Date: 2017-07-14
南京康川济医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The ibuprofen-phenylephrine hydrochloride bilayer pharmaceutical composition and its ...

Method used

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  • Ibuprofen and phenylephrine hydrochloride-containing double-layer medicinal composition and preparation method thereof
  • Ibuprofen and phenylephrine hydrochloride-containing double-layer medicinal composition and preparation method thereof
  • Ibuprofen and phenylephrine hydrochloride-containing double-layer medicinal composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Preparation of Ibuprofen-Phenylephrine Hydrochloride Double Layer Tablets (1000 Tablets Quantity)

[0037]

[0038] The preparation steps are:

[0039] Ibuprofen sustained-release layer: Mix ibuprofen, lactose and HPMC K100LV thoroughly, add appropriate amount of 30% ethanol to prepare soft material, wet granulate with 20 mesh sieve, dry at 50°C, dry granule with 18 mesh sieve, add prescription amount Mix stearic acid and micropowder silica gel evenly to obtain ibuprofen sustained-release layer granules;

[0040] Phenylephrine hydrochloride immediate-release layer: fully mix phenylephrine hydrochloride, lactose, microcrystalline cellulose and cross-linked carboxymethyl cellulose, add prescription amount of stearic acid and micropowder silica gel and mix evenly to obtain deoxygenated hydrochloride Epinephrine immediate release layer powder;

[0041] The ibuprofen sustained-release layer granules and the phenylephrine hydrochloride quick-release layer powde...

Embodiment 2

[0042] Embodiment 2 The preparation of ibuprofen-phenylephrine bilayer tablet (quantity of 1000 tablets)

[0043]

[0044]

[0045] The preparation steps are:

[0046] Ibuprofen slow-release layer: Mix ibuprofen, lactose and HPC-L thoroughly, add appropriate amount of 30% ethanol to prepare soft material, wet granule with 20 mesh sieve, dry at 50°C, dry granule with 18 mesh sieve, add prescription Amount of stearic acid and micropowder silica gel are mixed uniformly to obtain ibuprofen sustained-release layer granules;

[0047] Phenylephrine hydrochloride immediate-release layer: Mix phenylephrine hydrochloride, lactose, microcrystalline cellulose and crospovidone thoroughly, add stearic acid and micropowder silica gel in the prescribed amount and mix evenly to obtain phenylephrine hydrochloride Vegetarian immediate-release layer powder;

[0048] The ibuprofen sustained-release layer granules and the phenylephrine hydrochloride quick-release layer powder are respective...

Embodiment 3

[0049] Embodiment 3 The preparation of ibuprofen-phenylephrine bilayer tablet (quantity of 1000 tablets)

[0050]

[0051] The preparation steps are:

[0052] Ibuprofen slow-release layer: Mix ibuprofen, lactose and sodium alginate well, add appropriate amount of 30% ethanol to prepare soft material, wet granules with 20 mesh sieve, dry at 50°C, dry granules with 18 mesh sieve, add prescription Amount of stearic acid and micropowder silica gel are mixed uniformly to obtain ibuprofen sustained-release layer granules;

[0053] Phenylephrine hydrochloride immediate-release layer: Mix phenylephrine hydrochloride, lactose, microcrystalline cellulose and dry starch thoroughly and evenly, add stearic acid and micronized silica gel in the prescribed amount and mix to form an immediate-release layer powder.

[0054] Phenylephrine hydrochloride immediate-release layer: Mix phenylephrine hydrochloride, lactose, microcrystalline cellulose and dry starch thoroughly, add stearic acid and ...

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Abstract

The invention provides an ibuprofen and phenylephrine hydrochloride-containing double-layer medicinal composition. The ibuprofen and phenylephrine hydrochloride-containing double-layer medicinal composition is characterized in that the ibuprofen and phenylephrine hydrochloride-containing double-layer medicinal composition is a double-layer tablet consisting of an ibuprofen sustained-release layer and a phenylephrine hydrochloride fast-release layer; the ibuprofen sustained-release layer contains 100mg-500mg of ibuprofen; and the phenylephrine hydrochloride fast-release layer contains 5mg-30gm of phenylephrine hydrochloride. The ibuprofen and phenylephrine hydrochloride-containing double-layer tablet has the beneficial effects that the ibuprofen and the phenylephrine hydrochloride are respectively prepared into particles or powder, and then the particles or powder is compressed into the double-layer tablet; the phenylephrine hydrochloride fast-release layer realizes the fast release of medicines, quickly takes effect and relieves symptoms such as nasal obstruction, running nose and sneezing; the ibuprofen sustained-release layer realizes the sustained release of medicines and persistently relieves cold associated symptoms such as headache, fever, nasal obstruction and mild body pain; and meanwhile, the double-layer tablet can reduce the drug-drug interaction and improves the stability of preparations.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a double-layer medicinal composition containing ibuprofen and phenylephrine hydrochloride and a preparation method thereof. Background technique [0002] Ibuprofen is a propionic acid derivative and belongs to the non-steroidal anti-inflammatory drug (NSAID) with analgesic, antipyretic and anti-inflammatory properties. The analgesic and anti-inflammatory mechanism of ibuprofen has not been fully elucidated. It may act on local inflammatory tissues by inhibiting the synthesis of prostaglandins or other transmitters. Due to the inhibition of leukocyte activity and release of lysosomal enzymes, local tissue Reduced pain impulses and decreased sensitivity of pain receptors. [0003] Phenylephrine hydrochloride is a sympathomimetic drug, which mainly acts directly on α1-adrenergic receptors, and belongs to selective α1-adrenergic receptor agonists. At therapeutic doses, th...

Claims

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Application Information

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IPC IPC(8): A61K31/192A61K31/137A61K9/24A61K47/38A61P11/02A61P29/00
CPCA61K9/2054A61K9/2086A61K31/137A61K31/192A61K2300/00
Inventor 尹来生朱春莉陈金脱王微
Owner 南京康川济医药科技有限公司
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