New sulfamonomethoxine sodium crystal form and preparation method thereof

By preparing a new crystal form of ethanol solvate of sulfamethoxazole sodium, the induction period and fluidity of the crystallization process are improved, the problem of fine crystals and easy water absorption and deliquescence in the prior art is solved, and simplified industrial production is achieved.

CN120665017APending Publication Date: 2025-09-19ZHEJIANG RAYBOW PHARMACEUTICAL CO LTD
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Patent Information

Application Number
CN202510775377.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-06-11
Publication Date
2025-09-19

AI Technical Summary

Technical Problem

In the existing process, the crystallization process of sulfamethoxazole sodium has the problems of a long induction period, fine crystals and easy water absorption and deliquescence, which makes stirring and filtration difficult.

Method used

A new crystal form of an ethanol solvate of sulfamethoxazole sodium and a preparation method thereof are adopted. The steps include adding sulfamethoxazole to an alkaline alcohol solvent without nitrogen protection, cooling the solvent for crystallization, heating and holding the solvent, then slowly cooling the solvent and vacuum drying the solvent. The water content and temperature of the solvent are controlled to improve the crystallization process.

Benefits of technology

The prepared sulfamethoxazole sodium ethanol solvate has good fluidity, solves the deliquescence problem, simplifies the preparation process, and is suitable for industrial production.

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Abstract

The invention provides an ethanol solvate of sulfamonomethoxine and a method for preparing the ethanol solvate of sulfamonomethoxine. The invention relates to a sulfamonomethoxine sodium crystal, in particular to an ethanol solvate of 4-amino-N-(2, 6-dimethoxy-4-pyrimidine) benzenesulfonamide monosodium salt, the crystal serving as a seed crystal can improve the crystallization process of sulfamonomethoxine sodium and has good fluidity, the obtained material has no obvious hygroscopicity, the preparation process is simple and easy to implement, and the crystal is suitable for industrial production.
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