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Duloxetine hydrochloride sustained release medicine

A duloxetine hydrochloride and drug technology, which is applied in the field of duloxetine hydrochloride sustained-release drugs, can solve problems such as adverse reactions, limit clinical drug dosage, etc., achieve strong drug efficacy, enhance drug compliance and clinical treatment effect, Smooth and long-lasting effect of plasma concentration and drug action

Active Publication Date: 2009-08-12
CHONGQING SHENGHUAXI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although the adverse reactions of this drug are relatively small among comparable drugs of the same kind, there are still obvious adverse reactions during the medication process, especially nausea in the gastrointestinal tract is the most obvious, and the incidence rate can be as high as 23% to 28%. And it is also the main reason for patients to discontinue treatment, limiting the clinical dosage

Method used

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  • Duloxetine hydrochloride sustained release medicine
  • Duloxetine hydrochloride sustained release medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Get 15 parts of hydroxypropylmethylcellulose K15M (weight, the same below) 9.5 parts of glycine, 9.5 parts of sodium carboxymethylcellulose and 37.5 parts of lactose, pulverize, sieve, mix, and then mix with duloxetine hydrochloride Mix 28 parts evenly, add an appropriate amount of medicinal ethanol solution of polyacrylic resin II as a binder, make a soft material, granulate through a 18-mesh sieve, and obtain wet granules. The wet granules are ventilated and dried at 50°C, sieved through a 18-mesh sieve, and an appropriate amount of magnesium stearate is added, and blended to make them uniform to obtain mixed dry granules. Sampling for determination of intermediate content. Calculate the weight of the tablet to be pressed according to the determination of the intermediate content, and press it into a tablet with a φ7 deep concave die, with a hardness of 8 to 10 kg, and then coat it with an enteric-coated material to make 40 mg of duloxetine hydrochloride (take duloxet...

Embodiment 2

[0029] Take 13.5 parts of hydroxypropylmethylcellulose K100M, 10.5 parts of glycine, 6.5 parts of sodium carboxymethylcellulose and 26.5 parts of compressible starch, grind, sieve, mix well, and then mix with 42 parts of duloxetine hydrochloride Mix evenly, add an appropriate amount of polyacrylic acid resin II medicinal ethanol solution as a binder, make a soft material, pass through a 18-mesh sieve and granulate to obtain wet granules. The wet granules are ventilated and dried at 50°C, sized through a 18-mesh sieve, added with magnesium stearate, and blended to make them uniform to obtain mixed dry granules. Sampling for determination of intermediate content. Calculate the weight of the tablet to be pressed according to the measurement result of the intermediate content, and press it into a tablet with a hardness of 8 to 10 kg, and then coat it with an enteric-coated material to make a slow tablet containing 60 mg of duloxetine hydrochloride (calculated as duloxetine) / tablet...

Embodiment 3

[0031] Take 16 parts of carbomer 940P, 10.5 parts of glycine, 8 parts of low-substituted hydroxypropyl cellulose, and 11.5 parts of lactose, pulverize, sieve, mix well, then mix well with 55 parts of duloxetine hydrochloride, add appropriate amount Ethyl cellulose solution is used as a binder to make soft materials, and granulated through a 18-mesh sieve to obtain wet granules. The wet granules are ventilated and dried at 50°C, sized through a 18-mesh sieve, added with magnesium stearate, and blended to make them uniform to obtain mixed dry granules. Sampling for determination of intermediate content. Calculate the weight of the tablet to be pressed according to the determination result of the intermediate content, and press it into a tablet with a hardness of 8 to 10 kg, and then coat it with an enteric-coated material to make a slow tablet containing duloxetine hydrochloride 120mg (calculated as duloxetine) / tablet. release tablet.

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Abstract

Duloxetine hydrochloride sustained-release medicine is composed of duloxetine hydrochloride and acceptable excipients in oral medicine, wherein duloxetine hydrochloride is 15% to 65% of the total weight of the drug, and the excipients are At least include polymer matrix slow-release materials, release rate regulating components and enteric coating materials, and polymer matrix slow-release materials are 1% to 80%, release rate regulating components are 0.1% to 50%, enteric coating materials The coating material is 1.5% to 10%. The drug has a skeleton-type slow-release function of intestinal erosion, quick onset, strong drug effect, and prolonged action time, which can significantly reduce the adverse reactions of instantaneous drug release after taking the drug, make the blood drug concentration and drug effect more stable and durable, and enhance Patient compliance and clinical treatment outcomes.

Description

technical field [0001] The invention relates to a medicine with enteric-coated slow-release function, more specifically a duloxetine hydrochloride slow-release medicine. Background technique [0002] Duloxetine hydrochloride is currently used for diseases such as depression and diabetic neuralgia, and for the treatment of female urinary incontinence. The method is to take it in divided doses according to the prescribed time every day. [0003] The chemical structure of duloxetine hydrochloride is as formula (I). [0004] [0005] Although the adverse reactions of this drug are relatively small among comparable drugs of the same kind, there are still obvious adverse reactions during the course of medication, especially nausea in the gastrointestinal tract is the most obvious, and the incidence rate can be as high as 23% to 28%. And it is also the main reason for patients to discontinue treatment, which limits the clinical dosage. Contents of the invention [0006] In ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/381A61K9/28A61P25/04A61P25/24
Inventor 钟声荣姜维平贾春荣
Owner CHONGQING SHENGHUAXI PHARMA CO LTD
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