Menbutone sodium hydrate, preparation method therefor, and use thereof

Menbutone sodium hydrate is prepared by the parallel flow dissolution method, which solves the problem of poor water solubility of menbutone, achieves high solubility and rapid dissolution, improves the processability and stability of the preparation, and is suitable for the treatment of animal digestive system diseases.

WO2025200759A1 Publication Date: 2025-10-02RINGPU TIANJIN BIOLOGICAL PHARMA +1
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Patent Information

Application Number
PCT/CN2025/074111
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-03-29
Filing Date
2025-01-23
Publication Date
2025-10-02

AI Technical Summary

Technical Problem

Menbutone has poor water solubility, which leads to problems such as uneven mixing, uncontrollable dosage and strong local irritation in the application of existing powders and injections. In addition, the solubility of the existing crystal form is insufficient to meet clinical needs.

Method used

Menbutone sodium hydrate is prepared by crystallization using a parallel flow dissolution method. Through a specific solvent system and temperature control, menbutone sodium hydrate crystals are formed, which have good solubility and dissolution rate, and overcome the local supersaturation problem of the dissolution method.

Benefits of technology

The water solubility of menbutone sodium hydrate increases by 171 times, the dissolution rate is fast, the mixing performance is good, the impurity removal effect is significant, it is suitable for industrial production, and has good storage stability.

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Abstract

The present invention belongs to the technical field of chemical drug crystallization. Disclosed are a menbutone sodium hydrate, a preparation method therefor, and a use thereof. The structure of the menbutone sodium hydrate is as shown in formula (I): The menbutone sodium hydrate has characteristic peaks at 2θ values of 10.3±0.2°, 10.7±0.2°, 12.0±0.2°, 14.3±0.2°, 15.1±0.2°, 16.5±0.2°, 18.9±0.2°, 25.2±0.2°, and 26.5±0.2° in an X-ray powder diffraction pattern measured using CuKa radiation. The menbutone sodium hydrate of the present invention has good solubility and dissolution rate, excellent formulation processability, high crystallization purity and good storage stability, and has broad prospects for clinical application.
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