Clonidine hydrochloride sustained-release tablet composition and preparation method thereof

Abstract

The invention provides a clonidine hydrochloride-containing pharmaceutical composition and a preparation method thereof, particularly relates to a clonidine hydrochloride sustained-release tablet preparation and a preparation method thereof, and belongs to the field of pharmaceutical preparations. According to the invention, a polyvinyl acetate-povidone mixture is used as a sustained-release matrix material, and a sustained-release matrix tablet is prepared by combining the matrix material with clonidine hydrochloride and auxiliary materials in a specific ratio and adopting a powder direct compression method. The sustained-release matrix tablet prepared from the polyvinyl acetate-povidone mixture is high in hardness and low in friability, and the sustained-release matrix tablet can uniformly release drugs within 24 hours. The sustained-release tablet prepared by the powder direct compression method is uniform in content and stable in quality. The preparation process is simple, good inreproducibility and suitable for industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing clonidine hydrochloride and a preparation method thereof, in particular to a clonidine hydrochloride sustained-release tablet preparation and a preparation method thereof. Background technique [0002] ADHD is a common behavioral disorder in children, also known as Attention Deficit Hyperactivity Disorder (ADHD). Hyperactivity, emotional hyperactivity with cognitive impairment and learning difficulties, normal or near normal intelligence. According to domestic epidemiological surveys, the prevalence of ADHD in school-age children in my country is 4.31% to 5.83%, which means that nearly 20 million children in China suffer from ADHD, and about 50% to 60% of children with ADHD symptoms will continue to adults Even for life. [0003] At present, the main treatment methods include psychotherapy, drug therapy and their combination, behavior modification and EEG biofeedback therapy, among which...

AI Technical Summary

Problems solved by technology

[0004] Patent 201510887297.2 discloses a sustained-release capsule of clonidine hydrochloride. The sustained-release material is a composition of hydroxymethylcellulose and sodium alginate. It is a hydrophilic gel matrix sustained-release preparation, but the stability of the prepared preparation is poor; Patent 201811454995.3 discloses a slow-release preparation using clonidine hydrochloride and scutellarin polymer matrix composed of methyl cellulose and polyvinyl alcohol. The preparation has a hydrophobic material methyl cellulose and a hydrophilic material polyvinyl alcohol The two materials work together to regulate the release, and the slow-release effect requires a higher ratio between the two materials, which is not conducive to industrial production

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