中国药业2016，Vol.25Issue(24)：19-21,3.
近红外光谱法用于前列地尔注射液一致性检验模型研究
Research of Conformity Test on Alprostadil Injection by Near Infrared Spectrometry
摘要
Abstract
Objective To apply near infrared absorption spectrometry to establish conformity test model of Alprostadil Injection. Methods 54 batches of Alprostadil Injection were collected from 4 factories. The consistency of the NIR spectra were tested. The consistency test model was established and the quality and discrimination rate of each model were compared. Results Maked up con-formity test model unmistakably distinguished the clessification of samples of test collection. Conclusion The near-infrared diffuse re-flectance spectroscopy (NIRS) is a reliable and reliable method for the determination of Alprostadil Injection. The method has the ad-vantages of stability,feasibility,simple operation and high accuracy,which is suitable for drug detection and rapid screening of Al-prostadil Injection.关键词
近红外光谱法/前列地尔注射液/一致性检验模型Key words
near-infrared spectroscopy/alprostadil injection/conformity test model分类
医药卫生引用本文复制引用
郭雷,丁锐,邵天舒,周长明..近红外光谱法用于前列地尔注射液一致性检验模型研究[J].中国药业,2016,25(24):19-21,3.基金项目
国家药典委员会国家药品标准提高研究课题，项目编号753。 （）
