盐酸倍他司汀氯化钠注射液质量分析
Quality Analysis of Betahistine Hydrochloride and Sodium Chloride Injection
陈燕 1齐衍超 1聂晓华1
作者信息
- 1. 潍坊市检验检测中心,山东 潍坊 261000
- 折叠
摘要
文章对 44 批次盐酸倍他司汀氯化钠注射液依据法定标准进行了检验,同时开展了有关物质、盐酸倍他司汀含量测定新方法的研究,并检验了渗透压摩尔浓度.按照法定标准检验,44 批盐酸倍他司汀氯化钠注射液的合格率为100%,有关物质探索性研究检出杂质 2-吡啶乙醇和 2-乙烯基吡啶,且 2-乙烯基吡啶含量较高.结果表明,盐酸倍他司汀氯化钠注射液总体质量较好,生产工艺有待进一步提升,检验标准有待完善.
Abstract
In this paper,44 batches of betahistine hydrochloride and sodium chloride injection were tested according to the legal standards.At the same time,the related substances and the new method for the content of betahistine hydrochloride were studied,and the osmolality was detected.According to the legal standard,the qualified rate of 44 batches of betahistine hydrochloride sodium chloride injection was 100%.The impurities 2-pyridine ethanol and 2-vinyl pyridine were detected in the exploratory study of relevant substances,and the content of 2-vinyl pyridine was high.The results showed that the overall quality of betahistine hydrochloride sodium chloride injection is good,the production process needs to be further improved and the test standard needs to be improved.
关键词
盐酸倍他司汀氯化钠注射液/质量分析/法定标准/探索性研究Key words
betahistine hydrochloride and sodium chloride Injection/quality analysis/legal standards/exploratory research引用本文复制引用
出版年
2024
NETL
NSTL
维普
万方数据