近红外和拉曼光谱法对磷酸川芎嗪注射剂的鉴别研究  

Identification of Ligustrazine Phosphate Injection by Near Infrared and Raman Spectroscopy

作　　者：陶明[1] 李倚天 TAO Ming;LI Yi-tian(Henan Provincial Institute of Food and Drug Control,Henan zhengzhou 450018,China)

机构地区：[1]河南省食品药品检验所,河南郑州450018

出　　处：《中国药物评价》2020年第3期188-191,共4页Chinese Journal of Drug Evaluation

摘　　要：目的:应用近红外光谱法和拉曼光谱法分析技术,建立磷酸川芎嗪注射剂定性模型,快速无损进行磷酸川芎嗪注射剂的真伪鉴别。方法:以磷酸川芎嗪注射剂为研究主体,利用国家评价性抽验平台,从经营企业与医疗机构抽样57批次,根据生产工艺不同对注射用磷酸川芎嗪建立4个近红外一致性检验模型并进行验证,对磷酸川芎嗪氯化钠注射液建立拉曼定性模型并进行验证。结果:建立的近红外模型具有很好鉴别区分不同工艺生产的注射用磷酸川芎嗪的能力,并通过了不同人员和不同仪器的光谱验证。建立的拉曼模型,也能够区分磷酸川芎嗪氯化钠注射液真伪。结论:近红外和拉曼两种快检方法,可用于磷酸川芎嗪注射剂的鉴别,以及工艺一致性等质量评价。Objective:Applying Near infrared spectroscopy and Raman spectroscopy analysis techniques,a qualitative model of ligustrazine phosphate injection was established to quickly and nondestructively identify the authenticity of ligustrazine phosphate injection.Methods:With ligustrazine phosphate injection as the research subject,using the national evaluation sampling platform,57 batches of ligustrazine phosphate for injection were sampled from business enterprises and medical institutions.Four near infrared consistency test models were established and verified according to different production processes.A Raman qualitative model of ligustrazine sodium chloride injection was established and verified.Results:The NIR model has a good ability to distinguish ligustrazine phosphate for injection produced by different production processes,and has passed the spectral verification of different personnel and different instruments.The Raman model of ligustrazine phosphate and sodium chloride injection can also distinguish authenticity.Conclusion:The combination of near infrared spectroscopy and Raman spectroscopy can be used to identify ligustrazine phosphate injection and evaluate its quality.

关 键 词：近红外光谱 拉曼光谱 磷酸川芎嗪注射剂 快速检测 

分 类 号：R284[医药卫生—中药学]