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机构地区:[1]山东医学高等专科学校,山东济南250002 [2]济南金宏利实业有限公司,山东济南250100
出 处:《中国中药杂志》2008年第3期261-264,共4页China Journal of Chinese Materia Medica
基 金:山东省自然科学基金(Y2007C144);山东省教育厅科研项目(J07YD12)
摘 要:目的:建立一种用声光可调(AOTF)-近红外(NIR)光谱技术快速测定复方丹参片中丹参酮ⅡA和丹酚酸B的新方法。方法:依据2005年版《中国药典》复方丹参片含量测定方法,以HPLC测定其丹参酮ⅡA和丹酚酸B的含量,运用偏最小二乘(PLS1)法建立NIR光谱与2个成分HPLC分析值之间的多元校正模型,对未知样品进行含量预测。结果:建立的定量模型准确性好,丹参酮ⅡA、丹酚酸B的内部交叉验证均方差(RMSECV)分别是0.010 3,0.186 8,决定系数分别是0.987 3,0.983 2,并对外部验正集样品进行外部验证,丹参酮ⅡA、丹酚酸B预测值与真值的相关系数分别是0.974 3,0.988 6。该方法的精密度,稳定性好,RSD分别是1.756%,1.980%和1.193%,1.869%,预测回收率分别为103.0%,99.0%。结论:AOTF-近红外光谱法对复方丹参片中丹参酮ⅡA和丹酚酸B含量预测结果较好,为中药生产过程的在线、无损定量分析提供了依据。Objective: To establish a new method using AOTF-Near infrared spectroscopy (NIRS) for quick determination of tanshinone ⅡA and salvianolic acid B in Fufang Danshen tablets. Method: HPLC was used as a reference method to determine the contents of tanshinone ⅡA and salvianolic acid B in Fu Fang Dan Shen tablets. Multivariate calibration models based on PLS1 algorithm were developed to correlate the spectra and the corresponding values determined by the reference methods. Result: RMSECV (root-mean-square error of cross-validation)of the models for tanshinone ⅡA and salvianolic acid B were 0.010 3 and 0. 186 8 respectively. The correlation coefficients of the calibration models were 0. 987 3 and 0. 983 2 respectively. External validation with external validation samples proved that the relative coefficient of the predicted value and the truth value were R^2 =0. 974 3 and R^2 =0.988 6 respectively, with measured recycle rates of 103.0% and 99.0%. Conclusion: NIRS can be used in the determination of tanshinone ⅡA and salvianolic acid B, which sets up the foundation of product-line control of Fuang Danben tablets.
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