一种卡培他滨新晶型M及其制备方法

A new capecitabine crystal form M was prepared by magnetic treatment and ultrasonic-induced crystallization, which solved the stability and solubility problems of the existing crystal form, realized the stable storage and safe use of capecitabine, and reduced the formulation processing cost.

CN119735623BActive Publication Date: 2026-07-17UNIV OF JINAN

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
UNIV OF JINAN
Filing Date
2025-02-25
Publication Date
2026-07-17

AI Technical Summary

Technical Problem

Existing capecitabine crystal forms suffer from poor stability, unsuitable solubility for sustained-release formulations, and environmentally unfriendly solvent systems, affecting drug formulation processing and medication safety.

Method used

A novel capecitabine crystal form M was prepared by magnetic treatment, ultrasonic-induced crystallization, and controlled cooling rate. A rare-earth permanent magnet was used to apply a magnetic field outside the reactor, and combined with an alcohol solvent and a specific ultrasonic frequency, the cooling rate was controlled within a specific range to allow crystal growth.

Benefits of technology

The prepared capecitabine new crystal form M has good stability, is easy to store and transport, has moderate solubility, and uses environmentally friendly solvents, which reduces the cost of formulation processing and improves the safety of medication.

✦ Generated by Eureka AI based on patent content.

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Abstract

本发明涉及结晶技术领域,具体涉及一种卡培他滨晶型M,以及晶型M的制备方法。本发明所述晶型其特征在于X射线粉末衍射图在2θ±0.2°具有以下特征峰4.82、5.15、9.82、14.99、17.63、18.49、20.13、25.31、27.02、29.49。差示扫描量热分析(DSC)显示其在100~180℃之间只有一个吸热峰,其吸热峰顶值为124±2℃。热失重(TGA)分析显示该晶型是未溶剂化的,不含有结晶溶剂。本发明提供了一种卡培他滨新晶型M及该晶型的制备方法,该晶型稳定性佳,便于储存运输;该晶型制备工艺简单,易于工业化生产;溶剂体系绿色环保,无溶剂残留风险;该晶型溶解性与原研晶型基本一致,用药安全性更有保障,可大幅降低制剂加工工艺变更成本。这种新晶型的性质可以弥补现有晶型的种种不足,具有较高的经济效益及社会效益。
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