Preparation method of sterile cefuroxime sodium bulk drug

The invention belongs to the technical field of medical crystallization, and particularly relates to a preparation method of a sterile cefuroxime sodium bulk drug. The preparation method comprises the following steps: (1) dissolving a salt-forming agent in a mixed solvent A to obtain a salt-forming...

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Hauptverfasser: GONG JUNBO, WU SONGGU, GUO SHENGZHENG, YANG MENGDE, LI MIN, TANG WEIWEI, WANG LIJIE, QIAO JUNHUA, GAO ZHENGUO, WAN XUXING
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention belongs to the technical field of medical crystallization, and particularly relates to a preparation method of a sterile cefuroxime sodium bulk drug. The preparation method comprises the following steps: (1) dissolving a salt-forming agent in a mixed solvent A to obtain a salt-forming agent solution for later use; (2) dissolving cefuroxime acid in a mixed solvent B, stirring at 20-40 DEG C until the solution is clear, and sequentially decoloring, filtering and washing to obtain a cefuroxime acid solution for later use; and (3) controlling the temperature to be 30-45 DEG C, under the stirring condition, feeding the cefuroxime acid solution in the step (2) into the salt-forming agent solution at a constant flow acceleration rate of 25-50ml/min, carrying out reaction crystallization, filtering, washing a filter cake with a solvent C until the pH value of the filtrate is 7.5-8.5, and drying to obtain the sterile cefuroxime sodium bulk drug. The obtained cefuroxime sodium bulk drug is high in crystal