近红外光谱法快速测定右旋糖酐40葡萄糖注射液的含量

Development of a near IR method for rapid determination of Dextran 40 Glucose Injection

目的运用近红外透反射光谱分析技术和化学计量学方法对右旋糖酐40葡萄糖注射液进行无损、快速定量分析。方法以在全国范围内不同企业生产的右旋糖酐40葡萄糖注射液及实验室自制不同质量浓度的样品为分析对象,用光纤探头和液体测样附件测定近红外光谱,用偏最小二乘法(PLS)建立右旋糖酐40和葡萄糖定量模型。结果所建模型具有良好的预测能力,测定验证集中样品的含量,葡萄糖外部验证均方差(RMSEP)为0.749,右旋糖酐40外部验证均方差(RMSEP)为0.74;与药典标准方法相比,NIR法测定葡萄糖平均预测偏差为0.62,平均相对偏差为1.87%,右旋糖酐40平均预测偏差为0.59,平均相对偏差为1.53%。结论该方法快速无损,结果准确,可用于该制剂快速同时检测分析。

Objective To develop a method for rapid, non-destroyed determination of Dextran 40 Glucose Injection by near infrared spectroscopy technology and chemometrics. Methods The analytic samples from different pharmaceutical factories in China and la- boratory-made samples were determined by a fiber optic probe and liquid-like attachment. The partial least square （PLS） was applied to establish the model. Results The model had a good performance for prediction. The root mean square error of prediction （RMSEP） of glucose was 0. 749, and Dextran 40 was 0.74. Comparing with the standard method, the mean difference of prediction of glucose for test sets was 0.62 ,and the average relative deviation was 1.87%. The mean of prediction of Dextran 40 for test sets was 0.59,and the average relative deviation was 1.53 %. Conclusion The method is rapid, non-destroyed and accurate. It can be applied to the fast and simultaneous determination for the preparation.