文章摘要
张昦昉,卢海霞,王钧,刘畅,葛泽勋,李立坤.注射用伏立康唑细菌内毒素检查研究[J].中国药品标准,2023,24(1):
注射用伏立康唑细菌内毒素检查研究
Investigation on bacterial endotoxins test of voriconazole for injection
投稿时间:2022-08-11  修订日期:2023-02-02
DOI:
中文关键词: 注射用伏立康唑  细菌内毒素  质量标准  干扰试验  工艺水平
英文关键词: voriconazole for injection  bacterial endotoxins test  quality standards  interference test  technology
基金项目:
作者单位E-mail
张昦昉* 吉林省药品检验研究院 z17804301817@163.com 
卢海霞 吉林省药品检验研究院  
王钧 吉林省药品检验研究院  
刘畅 吉林省药品检验研究院  
葛泽勋 吉林省药品检验研究院  
李立坤 吉林省药品检验研究院  
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中文摘要:
      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1mg伏立康唑中含内毒素的量应小于0.75EU”,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。
英文摘要:
      Objective: To unify the quality standards of bacterial endotoxins in voriconazole for injection, avoiding multiple methods for determination of pyrogen and multiple limit values of bacterial endotoxin. Methods: According to general chapter 1143 bacterial endotoxins test in the Chinese Pharmacopoeia 2020 Vol IV, the limit of bacterial endotoxin of voriconazole for injection was determined, the interference test and bacterial endotoxin test was performed. Results: The limit value of bacterial endotoxins was set as‘No more than 0.75 Endotoxin Unit/mg of voriconazole’.The limit value of the bacterial endotoxins in 15 batches of samples made by two manufacturersmet the criteria. Conclusion: The established method can meet the safety requirement, and the technological level of the manufacturer can meet the requirement completely, and can be used for bacterial endotoxin test of voriconazole for injection.
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