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Pharmaceutic preparation of duloxetine hydrochloride and preparation method thereof

A technology of duloxetine hydrochloride and preparations, which is applied in the field of pellet medicine, and can solve problems such as adverse reactions and limitation of clinical dosage

Inactive Publication Date: 2013-07-24
BEIJING WANQUAN SUNSHINE MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although this drug has less adverse reactions among comparable drugs of the same kind, there are still obvious adverse reactions during the course of medication, especially nausea in the gastrointestinal tract, the incidence rate of which can be as high as 23%-28%, and It is also the main reason for patients to discontinue treatment, limiting the clinical dosage

Method used

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  • Pharmaceutic preparation of duloxetine hydrochloride and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Weigh 400g of microcrystalline cellulose, 100g of sucrose, mix evenly, add 180g of water to make soft material, extrude spheronizer to prepare blank core;

[0021] Take by weighing duloxetine hydrochloride crude drug 15g, be dispersed in the binder that is 3% hypromellose solution by weight that ethanol or ethanol / water mixture dissolve into, homogenizer high-speed shear Cut for 10 minutes;

[0022] Weigh 3g of hypromellose with water, ethanol or ethanol / water mixture to dissolve into a solution with a weight ratio of 3%, as an isolation layer;

[0023] Weigh 10g of acrylic resin, add water, ethanol or ethanol / water mixture to disperse, add 2.5g of triethyl citrate, 3g of talcum powder, add to hydroxypropyl methylcellulose after high-speed shearing by water, ethanol Or in the dispersion obtained by ethanol / water mixed liquid dispersion, stir for 30min;

[0024] Weigh 1.5g of triethyl citrate, 3g of titanium dioxide, and 4g of talc powder, and add to 100g of povidone o...

Embodiment 2

[0029] Weigh 300g of microcrystalline cellulose, 200g of sucrose, mix evenly, add 150g of water to make soft material, extrude spheronizer to prepare blank core;

[0030] Take by weighing duloxetine hydrochloride crude drug 20g, be dispersed in the binder that is 3% hypromellose solution by weight that ethanol or ethanol / water mixture dissolve into, homogenizer high-speed shear Cut for 10 minutes;

[0031] Weighing hypromellose 5g water, ethanol or ethanol / water mixed solution is dissolved into a solution with a weight ratio of 3%, as an isolation layer;

[0032] Weigh 15g of acrylic resin, add water, ethanol or ethanol / water mixture to disperse, add 3g of triethyl citrate, 5g of talcum powder, add to hydroxypropyl methylcellulose after high-speed shearing and add water, ethanol or In the dispersion obtained by dispersing the ethanol / water mixed liquid, stir for 30 minutes;

[0033] Weigh 3g of triethyl citrate, 2g of titanium dioxide, and 4g of talc powder, and add to 100g ...

Embodiment 3

[0038] Weigh 250g of microcrystalline cellulose, 250g of sucrose, mix evenly, add 180g of water to make soft material, extrude spheronizer to prepare blank core;

[0039] Take by weighing duloxetine hydrochloride crude drug 25, be dispersed in the binder that is 7% hypromellose solution by weight that is dissolved into by water, ethanol or ethanol / water mixture solution, homogenizer high-speed shear Cut for 10 minutes;

[0040] Weigh 10g of hypromellose with water, ethanol or ethanol / water mixed solution to dissolve into a solution with a weight ratio of 3%, as an isolation layer;

[0041] Weigh 15g of acrylic resin, add water, ethanol or ethanol / water mixture to disperse, add 2.5g of triethyl citrate, 3g of talcum powder, add to hydroxypropyl methylcellulose after high-speed shearing by water, ethanol Or in the dispersion obtained by ethanol / water mixed liquid dispersion, stir for 30min;

[0042] Weigh 3g of triethyl citrate, 2.5g of titanium dioxide, and 5g of talc powder,...

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Abstract

The invention belongs to the technical field of medicines, and in particular relates to a preparation method of duloxetine hydrochloride enteric coated drugs. The duloxetine hydrochloride is prepared by wrapping four layers of coating on a blank mini-pill, wherein the four layers of coatings are respectively a drug carrier layer, an isolation layer, a enteric coating layer and a film coating layer.

Description

technical field [0001] The invention relates to a pellet medicine with enteric-coating function, in particular to duloxetine hydrochloride enteric-coating pellets and a preparation method thereof. Background technique [0002] Duloxetine hydrochloride is currently used to treat depression and diabetic neuralgia and other diseases, as well as a drug with satisfactory curative effect on the treatment of female urinary incontinence. [0003] Its chemical structure is [0004] [0005] Although this drug has less adverse reactions among comparable drugs of the same kind, there are still obvious adverse reactions during the course of medication, especially nausea in the gastrointestinal tract, the incidence rate of which can be as high as 23%-28%, and It is also the main reason for patients to discontinue treatment, limiting the clinical dosage. Contents of the invention [0006] In view of the above situation, the present invention will provide a duloxetine hydrochloride ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/48A61K31/381A61P25/24A61P25/04A61P3/10A61P13/00
Inventor 张康黄雪任广智
Owner BEIJING WANQUAN SUNSHINE MEDICAL TECH CO LTD
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