Sotalol hydrochloride tablets and production technology thereof

Abstract

The invention belongs to the field of medicines, and provides sotalol hydrochloride tablets and a production technology thereof. According to the sotalol hydrochloride tablets and the production technology thereof, accessories of the sotalol hydrochloride tablets and the usages, especially the types of the accessories, are optimized, and the sotalol hydrochloride tablets are produced by conductingcrushing treatment on sotalol hydrochloride, making the crushed sotalol hydrochloride pass through an 80-mesh screen for treatment, and conducting tabletting directly after the crushed screened sotalol hydrochloride and the optimized accessories are mixed evenly. Compared with the prior art, the sotalol hydrochloride tablets and the production technology thereof have the advantages that the production technology is simple, the dissolving-out speed is high, and the medicine stability is good, so that the sotalol hydrochloride tablets are especially suitable for industrial production.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a sotalol hydrochloride tablet and a preparation process thereof. Background technique [0002] Sotalol hydrochloride is the only antiarrhythmic drug that has both β-receptor blockade and class III action potential (ADP) prolongation, and can also be used to treat angina pectoris and hypertension. The drug is a β-receptor blocker developed by Squibb. It was synthesized for the first time in 1960 and was approved by the FDA in 1992. Due to its remarkable curative effect, stable drug effect and few adverse reactions, it has been widely recognized clinically and is Used as a first-line drug for the treatment of sinus rhythm and atrial fibrillation. The chemical name of sotalol hydrochloride is: 4'-(1-hydroxy-2-isopropylaminoethyl) methanesulfonanilide hydrochloride, the structural formula is as follows: [0003] [0004] At present, preparations using sotalol hydrochloride as raw materi...

AI Technical Summary

Problems solved by technology

[0007] In the existing sotalol hydrochloride preparations, the tablet preparation process is mainly a wet granulation process, which is affected by humidity and heat factors during the preparation process, which is not conducive to the stability of the product. At the same time, the relatively complicated granulation process It also brings great inconvenience to the industrialized production of products.

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