复方苦参注射液两类中间体中生物碱含量的近红外光谱测定方法

目的: 建立复方苦参注射液两类中间体中4种生物碱含量的快速测定方法,探讨中药制剂中间体质量控制的有效途径。 方法: 以复方苦参注射液生产过程中的两类中间体——醇沉液和碱沉液为对象,分别采用近红外透射和透反射模式采集样品光谱,比较不同光谱采集方式的建模效果并优选出最佳建模参数,在此基础上采用偏最小二乘法(PLS)建立近红外光谱与参考值之间的校正模型,并对未知样品的含量进行预测。 结果: 建立的苦参碱、槐果碱、氧化槐果碱和氧化苦参碱模型性能良好。模型的预测误差均方根(RMSEP)分别为,醇沉液:0.131 g·L^-1、0.0279 g·L^-1、0.170 g·L^-1、0.613 g·L^-1;碱沉液:0.0723 g·L^-1、0.0155 g·L^-1、0.0768 g·L^-1、0.220 g·L^-1。 结论: 本实验所建方法快速、准确、可靠,可用于中药注射液中间体的快速分析。

Objective: To develop a rapid determination method for the quality control of the intermediates of compound Kushen injection based on NIRS (near infrared spectroscopy). Methods: After the comparison of different spectra collective modes (transmission and transflective) and optimization of the calibration parameters,multivariate calibration models based on PLS (partial least squares) algorithm were developed to correlate the transmission spectra and the reference values measured with standard method. Result: The root mean square errors of prediction (RMSEPs) of matrine,sophocarpine,oxysophocarpine and oxymatrine in the ethanol precipitate solution were 0.131 g·L^-1,0.0279 g·L^-1,0.170 g·L^-1,and 0.613 g·L^-1,respectively,while the RMSEPs of the alkali-precipitate solution calibration models were 0.0723 g·L^-1,0.0155 g·L^-1,0.0768 g·L^-1,and 0.220 g·L^-1,respectively. Conclusion: The established method is fast,accurate and reliable,which can be used as a rapid analysis method for the compound Kushen injection intermediates.