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A kind of atomoxetine hydrochloride oral solution and preparation method thereof

A technology of atomoxetine hydrochloride and oral solution, which is applied in the field of atomoxetine hydrochloride oral solution and preparation thereof, can solve the problems of difficult taking by patients, poor taste and the like, achieves high product stability, simple preparation method, and eliminates fear sense of effect

Active Publication Date: 2020-02-11
SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, medicines with bad odors taste bad after being made into liquid preparations, and it is difficult for patients to take them. Therefore, it is imminent to research and develop liquid preparations with good taste as children's medicines.

Method used

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  • A kind of atomoxetine hydrochloride oral solution and preparation method thereof
  • A kind of atomoxetine hydrochloride oral solution and preparation method thereof
  • A kind of atomoxetine hydrochloride oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] formula:

[0031]

[0032] Preparation Process:

[0033] 1) Preparation of the drug-containing solution: Dissolve the prescribed amount of β-cyclodextrin in 75ml of water at 40°C, add the prescribed amount of atomoxetine hydrochloride, tartaric acid, and sorbitol, stir to dissolve, and cool down to room temperature;

[0034] 2) Preparation of sucralose and preservative solution: dissolve the prescribed amount of sucralose, sodium methylparaben and sodium propylparaben in 5ml of water at room temperature;

[0035] 3) Add 2) into 1), stir evenly, add sodium citrate to adjust the pH value to neutral, add cherry essence, and dilute to 100ml with purified water to obtain the product.

Embodiment 2

[0037] formula:

[0038]

[0039] Preparation Process:

[0040] 1) Preparation of the drug-containing solution: Dissolve the prescribed amount of β-cyclodextrin in 75ml of water at 40°C, add the prescribed amount of atomoxetine hydrochloride, tartaric acid, and sorbitol, stir to dissolve, and cool down to room temperature;

[0041] 2) Preparation of sucralose and preservative solution: dissolve the prescribed amount of sucralose, sodium methylparaben and sodium propylparaben in 5ml of water at room temperature;

[0042] 3) Add 2) into 1), stir evenly, add sodium citrate to adjust the pH value to neutral, add cherry essence, and dilute to 100ml with purified water to obtain the product.

Embodiment 3

[0044] formula:

[0045]

[0046] Preparation Process:

[0047] 1) Preparation of the drug-containing solution: Dissolve the prescribed amount of β-cyclodextrin in 75ml of water at 40°C, add the prescribed amount of atomoxetine hydrochloride, tartaric acid, and sorbitol, stir to dissolve, and cool down to room temperature;

[0048] 2) Preparation of sucralose and preservative solution: dissolve the prescribed amount of sucralose, sodium methylparaben and sodium propylparaben in 5ml of water at room temperature;

[0049] 3) Add 2) into 1), stir evenly, add sodium citrate to adjust the pH value to neutral, add cherry essence, and dilute to 100ml with purified water to obtain the product.

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PUM

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Abstract

The invention relates to pharmaceutical composition containing atomoxetine hydrochloride and a preparation method of the pharmaceutical composition, in particular to an atomoxetine hydrochloride oral solution preparation and a preparation method thereof. Beta-cyclodextrin and tartaric acid are combined for taste masking treatment, the atomoxetine hydrochloride oral solution preparation with good taste is prepared, the preparation method is simple, the atomoxetine hydrochloride oral solution preparation has the good taste, large quantities of sweetening agents, flavors and fragrances are not added, the toxic and side effects are reduced, the defects of poor compliance of existing atomoxetine hydrochloride preparations for children and the like are overcome, the medication compliance of children patients is improved, and the clinical medication requirement of children is met.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing atomoxetine hydrochloride and a preparation method thereof, in particular to a atomoxetine hydrochloride oral solution preparation and a preparation method thereof. Background technique [0002] Atomoxetine hydrochloride: (-)-N-methyl-3-phenyl-3-(2-methylphenoxy)-propylamine hydrochloride, the structural formula is as shown in formula 1: [0003] [0004] It is the first non-stimulant drug for the treatment of attention deficit hyperactivity disorder (ADHD). The drug was developed by Lilly Company in the 1980s. It was originally intended to develop the product as an antidepressant, but it was terminated in the Phase III antidepressant trial in the early 1990s, but it failed in attention deficit hyperactivity disorder (attention deficit hyperactivity disorder). Disorder, ADHD) tests have shown effective results, and it was launched in the United States in January 2003. The trade name i...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/138A61K47/69A61K47/12A61P25/14
CPCA61K9/0053A61K9/08A61K31/138A61K47/12
Inventor 李树英兰颐吴学萍刘长涛何淑旺王英新王文笙王龙江
Owner SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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