右旋糖酐40氯化钠注射液近红外快速定量方法的建立

目的：利用近红外漫反射光谱分析技术和偏最小二乘法快速定量右旋糖酐40氯化钠注射液。方法：以4个厂家生产的42批右旋糖酐40氯化钠注射液为分析对象，首先采集样品的近红外漫反射光谱，同时以高效液相色谱法测定样品含量，然后采用偏最小二乘法建立定量模型。结果：采用内部交叉验证方法建立定量模型。右旋糖酐40含量范围为11.83%~60.84%，氯化钠为1.77%~9.09%；建模谱段为7 502~5 446 cm^-1和4 602~4 247 cm^-1；预处理方法为一阶导，17点平滑；维数为7；内部交叉验证相关系数右旋糖酐40为99.80%，氯化钠为99.78%；均方根误差右旋糖酐40为0.740%，氯化钠为0.115%；平均相对偏差右旋糖酐40为1.5%，氯化钠为1.6%。结论：所建立的快速分析定量模型可对右旋糖酐40氯化钠注射液进行准确、快速定量分析，绿色，环保，可用于药品的快速分析和检验。

Objective: To establish a fast quantitative method for dextran 40 and sodium chloride injection by near infrared reflection spectroscopy technology and partial least square algorithm.Methods: The 42 batches of dextran 40 and sodium chloride injection from 4 different manufacturers were chosen for analyzing.Firstly,collected the near infrared diffuse reflection spectrum of the samples were collected and the contents was determined by high performance liquid chromatography.Then the quantitative model was developed with the partial least square method.Results: The quantitative model was based on cross validation with the contents from 11.83%-60.84% for dextran 40 and 1.77%-9.09% for sodium chloride.The spectra ranges were 7 502-5 446 cm^-1 and 4 602-4 247 cm^-1;the pretreatment method was one derivation with 17 smooth points and the rank was 7.In the cross validation,the values of R² and root mean square error of cross validation (RMSECV) were 99.80% and 0.740% for dextran 40 and were 99.78% and 0.115% for sodium chloride,respectively.The average relative deviations were 1.47% for dextran 40 and 1.55% for sodium chloride.Conclusion: The method was accurate,quick,green,environmental friendly and convenient,and can be used for quick analysis in the drug quality control.