桂林西瓜霜喷剂中盐酸小檗碱快速含量测定方法的研究

Study on the quick determination of berberine hydrochloride in Guilin watermelon forst

目的:建立一种以声光可调(AOTF)-近红外(NIR)光谱技术快速测定桂林西瓜霜喷剂中盐酸小檗碱的新方法。方法:依据2005年版中国药典桂林西瓜霜喷剂含量测定的方法,以HPLC测定盐酸小檗碱的含量,运用偏最小二乘法(PLS1)建立NIR光谱与盐酸小檗碱HPLC分析值之间的校正模型,对未知样品进行含量预测。结果:建立的定量模型准确性好,盐酸小檗碱的内部交叉验证均方差(RMSECV)是0.2719,决定系数是0.9774,并对外部验正集样品进行外部验证,盐酸小檗碱预测值与HPLC法测定值的相关系数是0.9907,平均相对误差是3.299%。该方法的精密度、稳定性好,RSD分别是1.2%和1.3%。结论:AOTF-近红外光谱法可用于桂林西瓜霜喷剂中盐酸小檗碱快速含量测定,为其生产过程中的在线质量监控奠定了基础。

Objective：Based on determination of berberine hydrochloride in Guilin watermelon frost,a new method using AOTF-near infrared spectroscopy （NIRS） was established.Methods：According to Chinese Pharmacopoeia 2005 edition,HPLC was used as a reference method to determine the contents of berberine hydrochloride in Guilin watermelon frost.Multivariate calibration models based on PLS1 algorithm were developed to correlate the spectra and berberine hydrochloride values determined by the reference methods.Results：RMSECV（root-mean-square error of cross-validation） of the models for berberine hydrochloride was 0.2719.The correlation coefficients of the calibration models was 0.9774.External validation with external validation samples proved that the relative coefficient of the predicted value and the truth value for berberine hydrochloride was r2=0.9907.The mean relative error for test sets were 3.299%.This method was proved to be accurate,stable.RSD were 1.22% and 1.33% respectively.Conclusion：NIRS can be used in the determination of berberine hydrochloride in Guilin watermelon frost,which sets up the foundation of product-line control of guilin watermelon frost.