近红外光谱一致性检验模型快速鉴别氨酚曲马多片  

Rapid Identification of Aminophen Tramadol Tablets by Near Infrared Spectrum Consistency Test Model

作　　者：陈鸿玉 周明 吴琦琦 刘雁鸣 李晓燕 李昌亮 王晓菲 CHEN Hong-yu;ZHOU Ming;WU Qi-qi;LIU Yan-ming;LI Xiao-yan;LI Chang-liang;WANG Xiao-fei(Hunan Institute for Drug Control,Changsha 410001,China;Hunan Engineering&Technology Research Center for Pharmaceutical Quality Evaluation,Changsha 410001,China;Key Laboratory of pharmaceutical excipients engineering technology of State Drug Administration,Changsha 410001,China)

机构地区：[1]湖南省药品检验检测研究院,湖南长沙410001 [2]湖南省药品质量评价工程技术研究中心,湖南长沙410001 [3]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

出　　处：《海峡药学》2022年第10期18-21,共4页Strait Pharmaceutical Journal

基　　金：2020年国家药品评价性抽验专项。

摘　　要：目的 利用近红外快速分析技术建立鉴别氨酚曲马多片的分析方法。方法 采用3台不同型号的近红外光谱仪对36批次氨酚曲马多片进行测定,使用OPUS软件对相关近红外光谱图进行分析和处理,建立氨酚曲马多片的近红外光谱一致性检验模型。结果 建立的宜昌人福药业有限责任公司样品近红外一致性检验模型能够区别其他5个生产企业氨酚曲马多片样品。结论 所建立的方法能够快速鉴别不同企业生产的氨酚曲马多片,为用于控制氨酚曲马多片生产工艺并实现产品质量的一致性提供参考。OBJECTIVE To establish an analytical method for the identification of paracetamol tramadol tablets by near infrared rapid analysis technology.METHODS 36 batches of paracetamol tramadol tablets were determined by three different types of near-infrared spectrometers.The relevant near-infrared spectra were analyzed and processed by opus software.The near-infrared spectrum consistency test model of paracetamol tramadol tablets was established.RESULTS The established near infrared consistency test model of samples from Yichang Humanwell Pharmaceutical Limited liability company can distinguish the samples of paracetamol tramadol tablets from other five manufacturers.CONCLUSION The established method can quickly identify paracetamol tramadol tablets produced by different enterprises,and can be used to control the production process of paracetamol tramadol tablets and realize the consistency of product quality.

关 键 词：氨酚曲马多片 近红外光谱法 一致性检验模型 快速鉴别 

分 类 号：R927[医药卫生—药学]