国产注射用头孢美唑钠的质量评价

Quality Assessment of Domestic Cefmetazole Sodium for Injection

目的评价国产注射用头孢美唑钠的质量状况并分析存在问题和改进方法。方法按照法定检验方法进行样品检验,对有关物质、残留溶剂等项目进行探索性研究。结果法定检验有10批次不合格;探索性研究优化有关物质测定方法并推测出10个主要杂质的结构及来源;建立注射用头孢美唑钠的一致性快速近红外检验模型。结论国产注射用头孢美唑钠质量较好,国内企业头孢美唑钠生产工艺有待进一步提高。

OBJECTIVE To evaluate the quality status of the domestic cefmetazole sodium for injection.METHODS The statutory testing methods were used to test samples.The exploratory research were used to evaluate the quality of domestic cefmetazole sodium for injection.RESULTS There were 10 batchs unqualified in the statutory tests.The exploratory research optimized the determination method of related substances.And the structures and sources of 10 main impurities were characterized by liquid chromatography mass spectrometry.A rapid near infrared(NIR)model for the determination of cefmetazole sodium for injection were established.CONCLUSION The quality of most domestic cefmetazole sodium for injection meet current standards.The process of domestic cefmetazole sodium shall be improved.