摘 要 目的： 研究盐酸头孢替安的产业化工艺。方法： 考察放大实验中工艺的关键控制点对产品质量和收率的影响，对工艺关键控制点进行优化。结果： 在优化后的产业化工艺条件下制备得到的产品符合质量要求。结论：头孢替安产业化工艺研究达到预期结果，可用于工业化生产。

    关键词 盐酸头孢替安 工艺关键控制点 产业化

    中图分类号：TQ465.91 文献标志码：A 文章编号：1006-1533(2018)15-0070-02

    Study on the synthesis process for industrialization of cefotiam hydrochloride

    ZENG Chuiyu

    (Shanghai New Asia Pharmaceutical Co.， Ltd.， Shanghai 201203， China)

    ABSTRACT Objective： To study the synthesis process for industrialization of cefotiam hydrochloride. Methods： The effects of various parameters in the process on the quality and yield of cefotiam were investigated and the parameters of the key control points in the process were optimized. Results： The products obtained under the condition of the optimized industrial process could meet the quality requirements. Conclusion： The process for cefotiam industrialization can achieved the expected results and can be further used in industrial production.

    KEY WORDS cefotiam hydrochloride； key process control point； industrialization

    頭孢替安是日本武田药品工业株式会社研发的第二代头孢类抗生素 ......