| 摘要: |
| 头孢菌素是我国使用最为广泛的一类抗菌药物，其质量情况一直受到药品监管部门及患者的密切关注。头孢菌素一般采用微生物发酵物或其衍生物作为关键起始原料，经进一步的化学修饰或酶催化制得，头孢菌素最终的质量情况与关键起始原料的质量好坏密切相关。本文旨在讨论头孢菌素常用关键起始原料的质量控制策略，供相关研发及生产企业参考。 |
| 关键词: 头孢菌素 关键起始原料 质量控制 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.02.026 |
| 分类号:R943 |
| 基金项目: |
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| Discussion of Key Starting Materials Quality Control in Cephalosporin Antibiotics |
|
DENG Guifu
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Chongqing Institute for Food and Drug Control, Chongqing Engineering Research Center for Pharmaceutical Process and Quality Control, Collaborative Innovation Center for Chemical Medicine Quality Control and Evaluation, Chongqing 401121, China
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| Abstract: |
| Cephalosporins are the most widely used antibiotics in China. Their quality has been closely watched by the drug regulatory authorities and patients. Cephalosporins are usually prepared by chemical modification or enzyme catalysis with microbial ferments or derivatives thereof as a key starting material. The final quality of the cephalosporins is closely related to the quality of the key starting materials. This paper aims to discuss the quality control strategies for key starting materials commonly used for cephalosporins, which can be referred by relevant R&D and production companies. |
| Key words: cephalosporins key starting material quality control |
