Atomoxetine hydrochloride oral solution and preparation method thereof

Abstract

The invention discloses an atomoxetine hydrochloride oral solution for treating the attention deficit hyperactivity disorder, and a preparation method of the atomoxetine hydrochloride oral solution. The preparation comprises atomoxetine hydrochloride, hydroxypropyl-[beta]-cyclodextrin, pH regulating agent, preservative, essence, 50% ethyl alcohol and water. The preparation method comprises the following steps of: putting the water into a jar 1, carrying out stirring, adding the cyclodextrin, and carrying out dissolving to obtain a solution 1; putting 50% ethyl alcohol into a jar 2, carrying out stirring, adding the atomoxetine hydrochloride, and carrying out dissolving to obtain a solution 2; evenly mixing the solution 1 and the solution 2, transferring an obtained mixture into a grindingjar, carrying out grinding, adding the cyclodextrin, and after one hour, carrying out drying in an oven to obtain an intermediate 1; and putting the water in a preparation jar, adding the converted intermediate 1, sodium dihydrogen phosphate, phosphoric acid and sodium benzoate, carrying out stirring and dissolving, adding the essence, after the obtained mixture is even, measuring the pH value, controlling the pH value to 3.7-4.3, and obtaining 4.6mg / ml of atomoxetine hydrochloride oral solution. The oral aqueous solution improves the stability of the atomoxetine hydrochloride to a high degree, and a higher social value is brought.

Description

technical field

[0001] The invention belongs to the technical field of medicines and preparation methods thereof, and relates to a atomoxetine hydrochloride oral liquid and a preparation method thereof, the product of which significantly reduces the strong bitter taste of atomoxetine hydrochloride and improves medication compliance of children and adolescents sex. Background technique

[0002] Attention deficit hyperactivity disorder (ADHD), covering attention deficit disorder (English: Attention Deficit Disorder, abbreviated as ADD), is a common type of psychological disorder in childhood, which is not commensurate with age and developmental level inattention and short attention span, hyperactivity, and impulsivity, often with learning difficulties, conduct disturbance, and maladjustment, symptoms usually appear around age twelve and persist beyond six months in at least two contexts ( eg: school, family, leisure activities, etc.).

[0003] Currently, the main drugs recom...

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