Objective: To quantitatively analyze the content of glucose in glucose injection by near infrared spectroscopy to control the quality of the product.Methods: A quantitative model was established by near infrared reflectance spectroscopy and the injection came from pharmaceutical enterprises with different concentrations of glucose and the solution samples came from laboratories with different concentrations of glucose.The liquid sample accessories were selected, a quantitative model was established by a partial least squares method, and the effect of environmental temperature on the model was studied as well.Results: According to the quantitative model, the correlation coefficient reached up to 0.999 3, and RMS deviation (RMSECV) was 0.077 4.In the verification test, the results of various liquid formulas containing glucose were similar to those of the laboratory results.The prediction error was less than 5% within the temperature range of 20-35℃.Conclusion: The model of near-infrared partial least squares (PLS) can accurately predict the content of glucose in glucose products without sodium chloride, and can be used for the quality control of glucose intermediates and the finished products in the large infusion manufacturers%目的: 采用近红外光谱技术定量分析葡萄糖注射液中葡萄糖的含量,用于含葡萄糖制剂的快速检测及相关产品中间体质量控制.方法: 采用近红外光谱法进行建模,样品来源于企业生产的不同含量的葡萄糖注射液、实验室自制的不同浓度的葡萄糖溶液样品.选择液体测样附件,用偏最小二乘法建立定量模型,用各种含葡萄糖的溶液制剂进行验证,并考察模型对环境温度的耐受性.结果: 建立的近红外偏最小二乘(PLS)定量模型,相关系数达到0.999 3,交叉验证均方根误差(RMSECV)为0.077 4,验证试验中,各类含葡萄糖的液体制剂(不含氯化钠)预测的结果和实验室测定的结果一致,在20~35℃温度范围内,预测偏差小于5%.结论: 建立的模型可以准确地预测葡萄糖类产品中葡萄糖的含量,适用于大输液类生产厂家进行葡萄糖类产品中间体质量控制和成品的含量检测.
展开▼
