国产注射用盐酸头孢吡肟质量评价

Quality evaluation of domestic cefepime hydrochloride for injection

目的 评价国产注射用盐酸头孢吡肟的质量现状及存在问题。方法 依据法定质量标准,对上市产品进行检验,结合调研结果,开展探索性研究,综合评价上市产品质量。结果 163批次注射用盐酸头孢吡肟法定检验合格率为100%,但存在澄清度、酸度等边缘合格产品;探索性研究结果显示,法定标准在杂质控制、产品混合均匀性控制等方面存在一定不足;部分企业在胶塞选择、丙酮质量控制、残留溶剂控制水平等方面上存在一定问题。结论 国产注射用盐酸头孢吡肟质量较优,且近年有明显质量提升。建议修订质量标准,完善聚合物、有关物质、混合均匀性等控制;建议生产企业重视胶塞相容性研究、加强残留溶剂控制和丙酮质量管理,关注并研究产品中异亚丙基丙酮潜在安全风险。

Objective To evaluate the quality status and existing problems of domestic cefepime hydrochloride for injection. Methods The listed products were inspected according to the legal quality standards, exploratory research was carried out combined with the research results, and the quality of listed products was comprehensively evaluated. Results The qualified rate of 163 batches of cefepime hydrochloride for injection was 100%, but there were edge qualified products such as clarity and acidity;The exploratory research results show that the legal standard has some deficiencies in impurity control and product mixing uniformity control;Some enterprises have some problems in rubber stopper selection, acetone quality control and residual solvent control level. Conclusion The quality of domestic cefepime hydrochloride for injection is good, and has been significantly improved in recent years.It is suggested to revise the current standards and improve the control of polymers, related substances and mixing uniformity;It is suggested that manufacturers should pay attention to the research on the compatibility of rubber plugs,strengthen residual solvent control and acetone quality management, pay attention to and study the potential safety risks of isopropyl acetone in products.