盐酸倍他司汀注射液细菌内毒素方法学研究
Methodological investigation on bacterial endotoxin in betahistine hydrochloride injection
郝钢 1张莉芳 1武星 1颜皓 1赵雅婷 1韩峰1
作者信息
- 1. 内蒙古自治区药品检验研究院,呼和浩特 010020
- 折叠
摘要
目的:研究盐酸倍他司汀注射液细菌内毒素质量控制方法.方法:对5个厂家23批次的盐酸倍他司汀注射液进行细菌内毒素凝胶检查法的方法学研究.结果:本品内毒素限定值为3 EU·mg-1,适用《中国药典》2020年版四部通则1143项细菌内毒素检查法检查.结论:盐酸倍他司汀注射液可用细菌内毒素检查法进行质量控制,其细菌内毒素限值可以定为:每1 mg盐酸倍他司汀中含内毒素的量不得超过3.0EU.
Abstract
Objective:Investigation on the quality control method of bacterial endotoxin in betahistine hydrochlo-ride injection.Methods:The method of bacterial endotoxin gel test of 23 batches of betahistine hydrochloride injection from 5 manufacturers was studied.Results:The limit value of endotoxin in this product was 3 EU· mg-1,which was suitable for the bacterial endotoxin test of China Pharmacopoeia 2020.Conclusion:The quality of betahistine hydrochloride injection can be controlled by bacterial endotoxin test,and the limit of bacterial endotoxin can be set as follows:the content of endotoxin in every 1mg of betahistine hydrochloride should not exceed 3 EU.
关键词
盐酸倍他司汀注射液/细菌内毒素/限值/干扰试验/质量控制Key words
betahistine hydrochloride injection/bacterial endotoxin/limits/interference test/quality control引用本文复制引用
出版年
2024
NETL
NSTL
万方数据