消旋山莨菪碱非铝塑包装片剂近红外鉴别模型的初探

Study on the identification of raceanisodamine tablets by near infrared spectroscopy

目的采用近红外漫反射光谱分析技术和模式识别技术建立消旋山莨菪碱非铝塑包装片剂定性分析模型用于该品种的鉴别。方法以8个生产厂家的消旋山莨菪碱为分析对象,采集近红外漫反射光谱,通过导数化和矢量归一化进行预处理,应用欧氏距离方法建立消旋山莨菪碱近红外鉴别数学模型。结果消旋山莨菪碱的定性分析模型的条件参数为：谱段为5 400-7 000 cm-1,光谱预处理方法为＂一阶导数法＋归一化＂,模型的阈值为0.603。并对模型进行了验证,能满足应用的要求。结论试验结果表明应用近红外光谱技术建立消旋山莨菪碱的定性分析模型是可行的,同时为模型更新提供了一个参考的方法。

Objective To develop an identification model of raceanisodamine tablets by diffuse reflection near-infrared spectroscopy and pattern recognition. Methods The diffuse reflectance spectra in the 12 000-4 000 cm- 1spectral coverage range of raceanisodamine tablets from eight different pharmaceutical factories were collected to establish the identification model. A mono-component near infrared model was established for raceanisodamine tablets. Results The parameters of the identification model for the raceanisodamine tablets was as follows： spectral range was 5 400-7 000 cm- 1,the pretreatment method was first derivative and normalization; the threshold was 0. 603. And the model was validated,which met the requirements of application. Conclusion The results showed that identification model for the raceanisodamine tablets by near infrared spectroscopy was feasible,which provided a reference method for the model updating.