一种琥珀酸亚铁四水合物晶型、制备方法以及药物组合物

By controlling the molar ratio of sodium hydroxide to succinic acid and the pH value, the preparation process of ferrous succinate tetrahydrate was optimized, solving the problems of low yield and easy oxidation in the existing technology, and realizing the preparation and application of ferrous succinate tetrahydrate with high yield and high stability.

CN119684116BActive Publication Date: 2026-07-17JINLING PHARMA

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
JINLING PHARMA
Filing Date
2023-09-22
Publication Date
2026-07-17

AI Technical Summary

Technical Problem

Existing methods for preparing ferrous succinate tetrahydrate have low yields and are easily oxidized, resulting in insufficient solubility and affecting iron absorption. Furthermore, the existing crystal forms exhibit instability during storage and clinical applications.

Method used

Ferrous succinate tetrahydrate was prepared under specific process conditions. By controlling the molar ratio of sodium hydroxide to succinic acid, controlling the pH value, and adding ferrous sulfate solution dropwise, the formation of basic salts was avoided, thereby improving reaction efficiency and purity and obtaining a stable crystal form.

Benefits of technology

It improves the yield and stability of ferrous succinate tetrahydrate, reduces the iron content, and improves flowability and compressibility, making it suitable for formulation molding.

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Abstract

本发明属于药物化学领域,公开了一种琥珀酸亚铁四水合物晶型,在其X射线衍射图中,在2θ角为7.34,12.0,15.05,16.53,19.27,21.25,23.82,30.58,36.07,37.05,38.15°处有特征峰。本发明琥珀酸亚铁四水合物晶型的亚铁含量高、高铁含量低,且稳定性较好。本发明还公开了一种所述的琥珀酸亚铁四水合物晶型的制备方法,该制备方法具有成本低、操作简单、收率高、重复性强等优点。本发明还公开了一种药物组合物,包含治疗有效量的琥珀酸亚铁四水合物和药用辅料。
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