近红外光谱一致性检验模型快速鉴别左羟丙哌嗪胶囊
Rapid Identification of Levodropropizine Capsules by Near Infrared Spectrum Consistency Test Model
韩曦羽 1石笑弋 2刘轶 2陈鸿玉 2郑金凤 2刘雁鸣 2李琦2
作者信息
- 1. 湖南省药品检验检测研究院,湖南长沙 410001
- 2. 湖南省药品检验检测研究院,湖南长沙 410001;湖南省药品质量评价工程技术研究中心,湖南长沙 410001;国家药品监督管理局药用辅料工程技术研究重点实验室,湖南长沙 410001
- 折叠
摘要
目的:采用近红外光谱快速检验技术建立左羟丙哌嗪胶囊的鉴别方法.方法:采用 3 台近红外光谱仪对来自两家生产企业共 12 批次左羟丙哌嗪胶囊进行测定,使用OPUS软件对相关近红外光谱图进行分析和处理,建立左羟丙哌嗪胶囊的近红外光谱一致性检验模型,用不同厂家样品进行验证.结果:建立的近红外一致性模型可以快速、准确地区别不同厂家生产的左羟丙哌嗪胶囊.结论:本方法快速简便、结果准确,可用于左羟丙哌嗪胶囊的快速筛查.
Abstract
Objective:Near-infrared spectrum rapid test technique is used to establish the identification method of levodropropizine capsules.Methods:A total of 12 batches of levodropropizine capsules from two manufacturers are determined using three near-infrared spectrometers,the relevant near-infrared spectrum maps are analyzed and processed using OPUS software,establishing a near-infrared spectrum consistency test model of levodropropizine capsules,and verified by near-infrared spectrum of samples from different manufacturers.Results:The established near-infrared spectrum consistency model can quickly and accurately distinguish levodropropizine capsules produced by different manufacturers.Conclusion:This method is quick and simple,with accurate results,and can be used for rapid screening of levodropropizine capsule.
关键词
左羟丙哌嗪胶囊/近红外光谱法/一致性检验模型Key words
levodropropizine capsule/near infrared spectroscopy/consistency test model引用本文复制引用
基金项目
湖南省自然科学基金科药联合基金项目(2022JJ80010)
出版年
2024
NETL
NSTL
万方数据