Atomoxetine hydrochloride oral solution and preparation method thereof

A technology for atomoxetine hydrochloride oral liquid and atomoxetine oral liquid is applied in the field of atomoxetine hydrochloride oral liquid and its preparation, which can solve problems such as poor compliance, toxic and side effects, and achieve good compliance and improved taste. , good therapeutic effect

Inactive Publication Date: 2018-11-13
YANTAI JUXIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Aiming at the deficiencies in the prior art, the present invention provides a atomoxetine hydrochloride oral liquid, which can effectively solve the problem of poor compliance of atomoxetine hydrochloride due to its bitter taste, avoid the toxic and side effects of flavoring agents, and reduce the sweetness In addition, the atomoxetine hydrochloride oral liquid has the functions of improving the patient's attention, assisting the body to discharge lead, and strengthening the brain. It has a very good promotion effect on the treatment of ADHD and improves the treatment efficiency. The preparation method of atomoxetine hydrochloride oral liquid

Method used

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  • Atomoxetine hydrochloride oral solution and preparation method thereof
  • Atomoxetine hydrochloride oral solution and preparation method thereof
  • Atomoxetine hydrochloride oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] The formula of the atomoxetine hydrochloride oral liquid that the present embodiment provides, is made up of following weight drug and adjuvant in every 100L atomoxetine hydrochloride oral liquid, as shown in table 1:

[0044] The formula table of atomoxetine hydrochloride oral liquid in the embodiment 1 of table 1

[0045]

[0046] Add 3kg of propylene glycol and 68.4kg of water into the preparation tank, start stirring, the stirring speed is 600rpm, preheat to 55°C, after stirring evenly, add 0.3kg of water-soluble phospholipid and 0.15kg of pectin in turn, 55°C Stir evenly to obtain the base solution; then add 0.46kg of atomoxetine hydrochloride, 0.1kg of vitamin C, 0.06kg of sodium benzoate preservative, 20kg of xylitol sweetener, 0.8kg of Sucralose sweetener, 3.2kg of sorbitol sweetener, 3kg of SC586893 LEMON-LIME NATURE FLAVOR, stirred evenly at 60°C to obtain an intermediate solution; slowly add 1.73kg of sodium dihydrogen phosphate di Hydrate and 0.07kg of p...

Embodiment 2

[0048] The formula of the atomoxetine hydrochloride oral liquid that the present embodiment provides, is made up of following weight drug and adjuvant in every 100L atomoxetine hydrochloride oral liquid, as shown in table 2:

[0049] The formula table of atomoxetine hydrochloride oral liquid in the embodiment 2 of table 2

[0050]

[0051] Add 3kg of propylene glycol and 68kg of water into the preparation tank, start stirring, the stirring speed is 600rpm, preheat to 60°C, after stirring evenly, add 0.2kg of water-soluble phospholipids and 0.2kg of pectin in turn, at 60°C Stir evenly to obtain the base solution; then add 0.50kg of atomoxetine hydrochloride, 0.05kg of vitamin C, 0.05kg of sodium benzoate preservative, 18kg of xylitol sweetener, 0.5kg of three Sucralose sweetener, 3kg of sorbitol sweetener, 6kg of SC586893 LEMON-LIME NATURE FLAVOR, stir well at 60°C to obtain an intermediate solution; slowly add 1.9kg of sodium dihydrogen phosphate dihydrate to the intermedia...

Embodiment 3

[0053] The formula of the atomoxetine hydrochloride oral liquid that present embodiment provides, is made up of following weight drug and adjuvant in every 100L atomoxetine hydrochloride oral liquid, as shown in table 3:

[0054] The formula table of atomoxetine hydrochloride oral liquid in the embodiment 3 of table 3

[0055]

[0056] Add 3kg of propylene glycol and 71kg of water into the preparation tank, start stirring, the stirring speed is 600rpm, preheat to 60°C, after stirring evenly, add 0.2kg of pectin, stir evenly at 60°C to obtain the base solution; Add 0.48kg of atomoxetine hydrochloride, 0.1kg of vitamin C, 0.05kg of sodium benzoate preservative, 20kg of xylitol sweetener, 0.5kg of sucralose sweetener, 3kg of Sorbitol sweetener, 1kg of SC586893 LEMON-LIMENATURE FLAVOR, stirred evenly at 60°C to obtain an intermediate solution; slowly add 1.7kg of sodium dihydrogen phosphate dihydrate and 0.2kg of phosphoric acid to the intermediate solution, stir evenly, Carry...

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Abstract

The invention discloses an atomoxetine hydrochloride oral solution which contains 2.0-4.0mg / mL of water-soluble phospholipid, 1.5-2.0mg / mL of pectin, 4.0-5.0mg / mL of atomoxetine hydrochloride, 0.5-1.0mg / mL of vitamin C, 0.5-0.6mg / L of preservative, 200-250mg / mL of sweetening agent, 0.1-60mg / mL of SC586893 LEMON-LIME NATURE FLAWOR, 16-20mg / mL of pH regulator, 4-6mg / mL of Tween, 30mg / mL of FLAVOR, and the balance of water. In the preparation process, high pressure homogenization, microfiltration and high temperature instantaneous sterilization technologies are adopted. The atomoxetine hydrochloride oral solution is good in taking compliance, has a function of assisting in lead detoxification of the body, and can effectively alleviate the pain of the patients and increase the treatment efficiency.

Description

technical field [0001] The invention relates to a atomoxetine hydrochloride oral liquid and a preparation method thereof, belonging to the technical field of medicines and preparation methods thereof. Background technique [0002] Attention deficit hyperactivity disorder (ADHD), known as ADHD in my country, is the most common neurodevelopmental disorder and one of the most prevalent mental health problems among school-age children. mental disorder. At present, the main recommended drugs for the treatment of attention deficit hyperactivity disorder are central stimulants and selective norepinephrine reuptake inhibitors. Compared with these two drugs, selective norepinephrine reuptake inhibitors have the advantages of less side effects, good tolerance, long-term use, and no addiction, among which selective norepinephrine reuptake inhibitors are representative drugs It is atomoxetine hydrochloride, atomoxetine hydrochloride can effectively inhibit the reuptake of norepinephrin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/138A61K47/36A61K47/24A61K47/22A61K47/26A61P39/02A61P25/28A61P25/14
CPCA61K9/0095A61K31/138A61K47/22A61K47/24A61K47/26A61K47/36A61P25/14A61P25/28A61P39/02
Inventor 王巨先
Owner YANTAI JUXIAN PHARMA
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