建立注射用还原型谷胱甘肽钠近红外光谱法快速比对模型的研究

Establishment of a rapid comparison model for near infrared spectroscopy of reduced glutathione sodium for injection

目的采用近红外光谱法建立快速鉴定进口药品"注射用还原型谷胱甘肽钠"的一致性检验模型。方法收集广州市药品检验所进口抽检的两个厂家的合格药品"注射用还原型谷胱甘肽钠",其中包括Pharminvest SPA厂家14批及BIOMEDICA FOSCAMA厂家2批,共16批。分别采用隔玻璃瓶底测和直接接触测两种方法采集每批样品的近红外漫反射光谱,在OPUS光谱分析软件的Setup Conformity Test模块中,选择谱段范围为:8998.9～7795.5cm^(-1)、7413.6～6985.5cm^(-1)、6823.5～4023.1cm^(-1),进行一阶导数化和矢量归一化预处理建立一致性检验模型。结果采用隔玻璃瓶底测方式采集的注射用还原型谷胱甘肽钠谱图建立的快速比对模型专属性和耐用性较好,可区分出两个厂家的样品。而采用直接接触测方式采集谱图所建立的快速比对模型专属性不可行,无法区分出两个厂家的样品。结论该玻璃模型可快速鉴别出两个厂家生产的注射用还原型谷胱甘肽钠,并可有效地应用于药品检测车的现场筛查打假中。

Objective To establish a consistency test model for rapid identification of imported drugs “reduced glutathione sodium for injection” by near infrared spectroscopy. Methods The qualified “reduced glutathione sodium for injection” from two manufacturers imported by Guangzhou Institute of Drug Control were collected, included14 batches from Pharminvest SPA and 2 batches from BIOMEDICA FOSCAMA,total 16 batches.Near-infrared diffuse reflectance spectra of each batch of samples were collected by two methods of glass bottle bottom measurement and direct contact measurement respectively.In the Setup Conformity Test module of OPUS spectral analysis software,the range of selected spectral bands were 8998.9-7795.5cm^-1,7413.6-6985.5cm^-1 and 6823.5 -4023.1cm^-1,the consistency test model was established by first derivative and vector normalization pretreatment. Results The rapid comparison model for spectrogram of reduced glutathione sodium for injection collected by glass bottle bottom measurement was more specific and durable,which could distinguish the samples of two manufacturers.However,it was not feasible to use the rapid comparison model established by spectrograms which collected by direct contact measurement,and it was impossible to distinguish the samples of two manufacturers. Conclusion The glass model can quickly identify the reduced glutathione sodium for injection produced by two manufacturers,and can be effectively used on-site screening and counterfeiting of drug testing vehicles.