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Duloxetine hydrochloride medicament composition, enteric sustained release preparation and preparation method thereof

A duloxetine hydrochloride, sustained-release preparation technology, applied in the field of medicine, can solve problems such as complicated steps and inconvenient operation, and achieve the effects of taking convenience, maintaining stability, and avoiding damage

Active Publication Date: 2014-03-19
QINGDAO HUANGHAI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are still other preparation methods mentioned in published patent applications that use more than two steps to prepare enteric-coated sustained-release preparations, but the above-mentioned preparation methods disclosed are complicated in steps and inconvenient to operate

Method used

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  • Duloxetine hydrochloride medicament composition, enteric sustained release preparation and preparation method thereof
  • Duloxetine hydrochloride medicament composition, enteric sustained release preparation and preparation method thereof
  • Duloxetine hydrochloride medicament composition, enteric sustained release preparation and preparation method thereof

Examples

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Effect test

Embodiment 1

[0031] The preparation method of duloxetine hydrochloride enteric-coated sustained-release preparation described in the present embodiment comprises the following steps:

[0032] 1. Take 18 parts of duloxetine hydrochloride, crush them through a 100-mesh sieve, and mix them with 51 parts of sodium alginate, 12 parts of calcium gluconate and 17 parts of lactose in a wet mixing granulator to prepare mixture A. spare;

[0033] 2. Dissolve the adhesive PVP K30 in 95% ethanol solution, stir evenly and add it to the mixture A, stir evenly, and prepare soft materials. Wet soft materials use a swinging granulator to pass through a 20-mesh sieve to obtain wet granules. Dry in bed at 45°C to obtain dry granules, mixture B;

[0034] 3. After the prepared mixture B is granulated through a 18-mesh sieve of a granulator, a lubricant magnesium stearate is added and mixed uniformly in a multi-directional motion mixer to obtain a mixture C.

[0035] 4. After sampling and measuring the conten...

Embodiment 2

[0041] The preparation method of duloxetine hydrochloride enteric-coated sustained-release preparation described in the present embodiment comprises the following steps:

[0042] 1. Take 15 parts of duloxetine hydrochloride, crush it through a 100-mesh sieve, put it into a wet mixing granulator with 48 parts of sodium alginate, 11 parts of calcium hydrogen phosphate, 8 parts of mannitol, and 16 parts of microcrystalline cellulose Mix well, prepare mixture A, set aside;

[0043] 2. Add the binder hydroxypropyl methylcellulose E5 to the 50% ethanol solution, stir evenly, add it to the mixture A, stir evenly, and prepare soft materials. Wet soft materials are made by passing through a 20-mesh sieve with a swinging granulator Wet granules are dried in an oven at 50°C to obtain dry granules, namely mixture B;

[0044] 3. After the prepared mixture B is granulated through a 18-mesh sieve of a granulator, a lubricant magnesium stearate is added and mixed uniformly in a multi-directi...

Embodiment 3

[0050] The preparation method of duloxetine hydrochloride enteric-coated sustained-release preparation described in the present embodiment comprises the following steps:

[0051] 1. Take 20 parts of duloxetine hydrochloride, crush them through a 100-mesh sieve, put 54 parts of sodium alginate, 10 parts of calcium citrate, and 14 parts of starch into a wet mixing granulator and mix evenly to prepare mixture A ,spare;

[0052] 2. Add the adhesive PVP K90 to the 95% ethanol solution, stir evenly and add it to the mixture A, and stir evenly to prepare soft materials. The wet and soft materials are passed through a 20-mesh sieve by a swinging granulator to obtain wet granules. Dry at 45°C to obtain dry granules, namely mixture B;

[0053] 3. After the prepared dry granules are sized by a 18-mesh sieve in a granulator, the lubricant magnesium stearate and micropowder silica gel are added and mixed uniformly in a multi-directional motion mixer to obtain mixture C.

[0054] 4. After...

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Abstract

The invention provides a duloxetine hydrochloride medicament composition, an enteric sustained release preparation and a preparation method thereof. The enteric sustained release preparation comprises the following components in parts by weight: 5-40 parts of duloxetine hydrochloride, 35-65 parts of sodium alginate, 5-20 parts of calcium salt, 15-35 parts of filler and 0.5-20 parts of lubricant. The medicament composition and the enteric sustained release preparation provided by the invention are hardly released under the gastric acid condition, so that a main medicine is prevented from being damaged in a stomach, no functional sustained release coating is needed to control medicine release, no enteric sustained release material is needed, only high-velocity sodium alginate and other medical auxiliaries are used, the enteric effect is achieved by adjusting the ratio, meanwhile the sustained release function is achieved, the medicine is effectively prevented from being damaged by the gastric acid environment, and the stability of the medicament inside a body in the absorption process is maintained.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition of duloxetine hydrochloride, an enteric-coated sustained-release preparation and a preparation method. technical background [0002] Duloxetine hydrochloride is a drug developed by Eli Lilly and Company for the treatment of major depression, generalized anxiety disorder, women's stress urinary incontinence, the relief of diabetic peripheral neuropathic pain and fibromyalgia. The drug was first launched in the United States in 2004. Its chemical name is (S)-(+)-N-methyl-3-(1-naphthyloxy)-3-(2-thiophene)-propylamine hydrochloride, and its chemical structure is as follows: [0003] [0004] Because duloxetine hydrochloride is unstable in the acidic gastric juice environment and is prone to degradation, it is a better choice to prepare duloxetine hydrochloride into enteric-coated tablets or capsules. The drug is not released in the gastr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/28A61K31/381A61K47/36A61K47/02A61K47/12A61P25/24A61P25/22A61P13/00A61P25/02A61P21/00A61P29/00
Inventor 尤恒刘少梅李振霞迟振尧刘晓华胡杰
Owner QINGDAO HUANGHAI PHARM CO LTD
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