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Paroxetine hydrochloride oral suspension and preparation process thereof

A technology of paroxetine hydrochloride and oral suspension, applied in the field of medicine, can solve the problems of poor taste, poor patient compliance, limited clinical application and the like

Inactive Publication Date: 2018-12-04
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because paroxetine hydrochloride has a bitter and numb feeling, the taste is not good, and the patient's compliance is poor, which greatly limits its clinical application.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] .

[0020] Preparation Process

[0021] (1) Paroxetine hydrochloride is pre-mixed with silicon dioxide through sieving, mixed evenly, and dispersed in propylene glycol to obtain a solution ;

[0022] (2) Take the prescribed amount of double distilled water, add the prescribed amount of glycerin and peppermint oil and mix well, add ethyl paraben and stir to dissolve; add the prescribed amount of sorbitol and sunset yellow in sequence to obtain solution II;

[0023] (3) the solution Mix with solution II, add citric acid and sodium citrate, stir to dissolve, adjust the pH of the solution to 5, and obtain a sample suspension;

[0024] (4) The sample suspension is subjected to high-pressure homogenization by a micro-jet high-pressure homogenizer. The homogenization pressure is 15,000 psi, and the number of homogenization is 20 times. Finally, simethicone and orange flavor are added. Example 2

Embodiment 2

[0025] .

[0026] Preparation Process

[0027] (1) Paroxetine hydrochloride is pre-mixed with silicon dioxide through sieving, mixed evenly, and dispersed in propylene glycol to obtain a solution ;

[0028] (2) Take the prescribed amount of double distilled water, add the prescribed amount of glycerin and clove oil, mix well, add methylparaben and stir to dissolve; add the prescribed amount of sodium saccharin and sunset yellow in sequence to obtain solution II;

[0029] (3) the solution Mix with solution II, add citric acid and sodium citrate, stir to dissolve, adjust the pH of the solution to 7, and obtain a sample suspension;

[0030] (4) The sample suspension is subjected to high-pressure homogenization by a micro-jet high-pressure homogenizer. The homogenization pressure is 10,000 psi, and the number of homogenization is 10 times. Finally, simethicone and orange flavor are added.

Embodiment 3

[0032] .

[0033] Preparation Process

[0034] (1) Paroxetine hydrochloride is pre-mixed with silicon dioxide through sieving, mixed evenly, and dispersed in propylene glycol to obtain a solution ;

[0035] (2) Take the prescribed amount of double distilled water, add the prescribed amount of glycerin and menthol, mix well, add benzoic acid and stir to dissolve; add the prescribed amount of acesulfame potassium and sunset yellow in sequence to obtain solution II;

[0036] (3) the solution Mix with solution II, add citric acid and sodium citrate, stir to dissolve, adjust the pH of the solution to 4, and obtain a sample suspension;

[0037] (4) The sample suspension is subjected to high-pressure homogenization by a micro-jet high-pressure homogenizer. The homogenization pressure is 8000 psi, and the number of homogenization is 20 times. Finally, simethicone and orange flavor are added.

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PUM

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Abstract

The present disclosure relates to the pharmaceutical field, and in particular, relates to a paroxetine hydrochloride oral suspension and a preparation process thereof. The paroxetine hydrochloride oral suspension is prepared by the steps: firstly, screening and pre-mixing raw material drugs with a suspending aid silicon dioxide, and then dispersing in propylene glycol; then adding a prescription amount of double distilled water, glycerin, a preservative, a taste bud paralysant, a sweetener, a colorant and a pH regulator, and adjusting the pH of the solution to 3-7; after uniform magnetic stirring, carrying out high pressure homogenization by a micro-jet high-pressure homogenizer; and finally, adding a foaming agent and an essence. The oral suspension masks the bitterness of drugs and is more acceptable to patients, wherein high pressure homogenization is performed by the micro-jet high-pressure homogenizer, and the prepared suspension has large sedimentation volume and is stable. The paroxetine hydrochloride oral suspension improves the compliance of patients, facilitates the use of children and adults with difficulty in swallowing oral solid preparations, ensures the accuracy of dosage of administration, and improves the safety and effectiveness of drugs.

Description

technical field [0001] The disclosure belongs to the technical field of medicine, and in particular relates to a paroxetine hydrochloride oral suspension and a preparation process thereof. Background technique [0002] Paroxetine hydrochloride was developed by SmithKline Beecham Corporation of the United States. It is a selective central nervous system serotonin reuptake inhibitor, which can increase the concentration of 5-serotonin in the synaptic cleft and exert an antidepressant effect. It has a weak effect on other transmitters and has little effect on the autonomic nervous system and cardiovascular system. Clinically used to treat depression. It can also treat obsessive-compulsive disorder, panic disorder, or social anxiety disorder. Because paroxetine hydrochloride has bitter numb feeling, bad mouthfeel and poor patient compliance, its clinical application is greatly limited. The disclosure provides a paroxetine hydrochloride oral suspension and a preparation method...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K47/04A61K31/4525A61P25/24
CPCA61K9/0095A61K9/10A61K31/4525A61K47/02
Inventor 王芳王宇杰
Owner AVENTIS PHARMA HAINAN
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