Tizanidine nitrate crystal form A, and preparation method and applications thereof

Abstract

The invention provides a tizanidine nitrate crystal form A, and a preparation method and applications thereof. The provided tizanidine nitrate crystal form A uses a Cu-K[alpha] radiation source to perform X-ray powder diffraction, and a 2[theta] diffraction angle has characteristic absorption peaks at 11.4 + / - 0.2, 20.8 + / - 0.2, 21.8 + / - 0.2, 23.2 + / - 0.2 and 26.7 + / - 0.2 degrees; the crystal formA is high in chemical purity, stable in property and low in hygroscopicity, and an effective solution can be provided for the improvement of the availability and security of drugs; and in addition, the crystal form A is simple in preparation technology, short in reaction time and high in product yield, and has no special requirements on equipment, so that the crystal form A is suitable for industrial production.

Description

technical field

[0001] The invention relates to a crystal form A of tizanidine nitrate, a preparation method and application of the crystal form, and belongs to the technical field of medicinal chemistry. Background technique

[0002] Tizanidine is an imidazoline diazoline derivative with the chemical name 5-chloro-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3 -Benzothiadiazol-4-amine, molecular formula: C 9 h 8 ClN 5 S, molecular weight: 253.71, its chemical structure is as follows:

[0003]

[0004] Tizanidine is the only new type of central skeletal muscle relaxant and central α2 adrenergic receptor agonist with gastrointestinal protective effect on the market. It was first developed by Swiss Novartis and first launched in Denmark in 1988. and Switzerland, and then successively obtained sales licenses in more than 20 countries including Europe, the United States, and Japan. It is clinically used to treat diseases such as increased skeletal muscle tension, muscle spasm an...

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