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

目的运用近红外漫反射光谱分析技术建立前列地尔注射液的一致性检验模型。方法收集4个厂家共54批前列地尔注射液,扫描近红外光谱图行一致性检验后,分别建立一致性检验模型,比较各模型的质量及区分率。结果该模型对待测试样品能准确分类。结论用近红外漫反射光谱分析技术对前列地尔注射液建立的一致性检验模型,具有方法稳定可行、简单易操作、准确率高等特点,适用于药品检测车对前列地尔注射液一致性的快速筛查。

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 conformity test model unmistakably distinguished the clessification of samples of test collection. Conclusion The near-infrared diffuse re-lectance spectroscopy （NIRS） is a reliable and reliable method for the determination of Alprostadil Injection. The method has the advantages of stability, feasibility, simple operation and high accuracy, which is suitable for drug detection and rapid screening of Alprostadil Injection.