近红外光谱法分析头孢拉定颗粒的关键质量属性及对其量值的测定

Analysis of the critical quality attributes of cefradine granules and determination of their quantity by near-infrared spectroscopy

目的利用国家评价性抽验平台数据库中的数据,探索头孢拉定颗粒质量关键质量属性及快速定量方法。方法应用近红外光谱结合因子分析建立模式识别方法,探索不同厂家头孢拉定颗粒质量和工艺的一致性;利用近红外光谱和偏最小二乘法建立定量模型,对头孢拉定颗粒中头孢拉定含量、头孢氨苄含量和水分含量进行快速量值预测。结果利用模式识别模型可区分不同厂家头孢拉定颗粒的质量和工艺一致性,建立的PLS定量模型能实现对头孢拉定含量、头孢氨苄含量和水分含量的快速预测。结论国家评价性抽验平台对为药品监管及靶向抽验提供有效的科学依据具有重要的价值。

Objective To explore critical quality attributes(CQAs) and rapid quantitative methods of cefradine granules by using the data in the database of national evaluation sampling platform. Methods This paper applied near-infrared spectroscopy(NIRS) combined with factor analysis to establish a pattern recognition method to explore the consistency of the quality and process of cefradine granules from different manufacturers. A quantitative model was established by using NIRS and partial least squares(PLS) method to rapid predict the cefradine content,cephalexin content, and water content in cefradine granules. Results The pattern recognition model can be used to distinguish the quality and process consistency of cefradine granules from different manufacturers. The established PLS quantitative model can realize the rapid prediction of cefradine content, cephalexin content, and water content.Conclusion The national evaluation sampling testing platform is of great value to provide effective scientific basis for drug supervision and targeted sampling testing.