注射用单磷酸阿糖腺苷细菌内毒素检查方法研究
Investigation on bacterial endotoxins test of vidarabine monophosphate for injection
陈素珍 1曾秋敏 1吴燕虹1
作者信息
摘要
目的:建立注射用单磷酸阿糖腺苷的细菌内毒素检测方法并进行方法学验证,以期对该品种的质量控制标准进行统一规范.方法:按照《中国药典》2020年版四部通则1143"细菌内毒素检查法",确定细菌内毒素的限值,进行干扰试验,并进行内毒素检查.结果:按经验拟定的限值标准(每1 mg单磷酸阿糖腺苷中含内毒素的量应小于0.06EU)对15个厂家提供的25个批次的供试品进行细菌内毒素检查,结果均符合规定.结论:本文建立的细菌内毒素检查法检查,可用于注射用单磷酸阿糖腺苷的质量控制.
Abstract
Objective:To establish a bacterial endotoxin detection method for vidarabine monophosphate for injection and conduct methodological validation for harmanizing the quality control standard of this product.Methods:According to the Chinese Pharmacopoeia 2020 volume Ⅳ general chapter 1143"Bacterial endotoxin test",the limit of bacterial endotoxin was determined,interference test and endotoxin testing were performed.Results:The bacterial endotoxin test were performed on 25 batches of test samples provided by 15 manufacturers according to the experienced experimented limitation which is the amount of endotoxin in 1 mg of adenosine mono-phosphate should be less than 0.06 EU.All results were found to be in compliance with the specified standards.Conclusion:The established bacterial endotoxin method can be used for quality control of vidarabine monophos-phate for injection.
关键词
注射用单磷酸阿糖腺苷/细菌内毒素/质量标准/干扰试验/凝胶法/鲎试剂Key words
vidarabine monophosphate for injection/bacterial endotoxin test/quality standards/interference test/gel-clot method/Tachypleus Amebocyte Lysate(TAL)引用本文复制引用
基金项目
广东省药品检验所2022年所内项目(SN2022018)
出版年
2024
NETL
NSTL
万方数据