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

作　　者：吴少平 李小安[1,2] 刘海静 郭欢迎 

机构地区：[1]陕西省食品药品检验所,陕西西安710061 [2]陕西中医学院,陕西咸阳712046

出　　处：《西北药学杂志》2011年第5期344-347,共4页Northwest Pharmaceutical Journal

摘　　要：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.

关 键 词：右旋糖酐40葡萄糖注射液 近红外光谱 偏最小二乘法 

分 类 号：R927.2[医药卫生—药学]