【作者】 孟昱； 王世盛； 蔡蕊； 赵伟杰；

【Author】 Meng Yu Wang Shisheng Cai Rui Zhao Weijie(State Key Laboratory of Fine Chemicals,School of Pharmaceutical Science and Technology,Dalian University of Technology,Dalian116023,China)

【机构】 大连理工大学制药工程与技术学院精细化工国家重点实验室；

【摘要】 本文采用近红外漫反射光谱法对来自制药企业生产车间的13种头孢菌素粉针剂原料进行无损、快速鉴别分析,65张谱图用于建立模型,13批样品用于验证。在4000-10000cm-1的范围内,使用矢量归一化和二阶导数9点平滑,结合因子分析法建立NIR头孢菌素定性分析模型。用验证方法进行验证,结果定性分析模型每类产品均被唯一区分,13批未知样品预测样品的判错率为0%。结果表明,研究结果表明用近红外光谱法对该十三种头饱菌素粉针剂原料进行定性分析结果准确可靠,方法简便快速,样品不需要预处理,适用于制药企业在原料进厂时逐桶定性鉴别和车间投料的过程控制。更多还原

【Abstract】 A rapid,accurate and no sample preparation required method was developed by near infared spectroscopy(NIR)to identify 13 kinds of Cephalosporin powder injection APIs for which were widly used in pharmaceuatical industry.65 NIR spectra were utilised to establish the calibration model and rest 13 spectra were utilised to validate the performance of the model.On the original data,Vector normalization and second derivative 9 point smoothing combined with factor analysis were conducted as the optimum pre-processing method at 4000～10000cm-1,and 13 Cephalosporin APIs could be well identified by this model.With this approach,no"error determinations"were assigned to a wrong class,which indicated this NIR method is accurate,simple and convenient,and is appropriate for the identifacation of Cephalosporin powder injection APIs in the GMP manufacture of drug products within the pharmaceutical industry.更多还原