摘要
目的:统一注射用伏立康唑细菌内毒素检查法质量标准,避免一药多项、一项多限的问题。方法:按照《中国药典》2020年版四部通则1143“细菌内毒素检查法”,确定细菌内毒素限值,进行干扰试验,并进行内毒素检查。结果:细菌内毒素限值定为“每1 mg伏立康唑中含内毒素的量应小于0.75 EU”,对两个公司生产的15批次样品进行细菌内毒素检查,结果均符合规定。结论:所建立的方法,可满足安全需要,且生产厂家的工艺水平也完全可以达到此要求,可用于注射用伏立康唑细菌内毒素检查。
Objective:To standardize the quality standard of bacterial endotoxin test for voriconazole for injection,and to avoid the problem of multi-drug and multi-limit.Methods:According to the Chinese Pharmacopoeia 2020 of four parts 1143“Bacterial endotoxin test”,to determine the limit of bacterial endotoxin,interference test,and endotoxin testing.Results:The bacterial endotoxin limit was set at“Less than 0.75 EU/1 mg of Voriconazole”and 15 batches of samples produced by both companies were tested for bacterial endotoxin and found to be in compliance.Conclusion:The established method can meet the safety requirements and the technology level of the manufacturer can meet the requirements.It can be used for the bacterial endotoxin test of voriconazole for injection.
作者
张昦昉
卢海霞
王钧
刘畅
葛泽勋
李立坤
ZHANG Haofang;LU Haixia;WANG Jun;LIU Chang;GE Zexun;LI Likun(Jilin Institute for drug control,Changchun 130033,China)
出处
《中国药品标准》
CAS
2023年第1期57-60,共4页
Drug Standards of China
关键词
注射用伏立康唑
细菌内毒素
质量标准
干扰试验
工艺水平
voriconazole for injection
bacterial endotoxins
quality standards
interference test
technology level
