近红外光谱分析技术快速分析银杏叶分散片半成品水分及含量

目的: 利用近红外光谱分析技术和化学计量学方法对银杏叶分散片制粒干燥后的中间产品(成品)含量和水分进行无损、快速分析,控制产品质量。方法: 采集银杏叶分散片生产过程中的中间产品近红外漫反射光谱(NIRDRS),采用偏最小二乘法(PLS)建立中间产品水分及含量(总黄酮醇苷和萜类内酯)定量分析模型。结果: 水分及含量(总黄酮醇苷、萜类内酯)定量分析模型的决定系数(R²)分别为0.9952、0.9668、0.9528;内部交叉验证均方根误差(RMSECV)分别为0.162、2.97、1.43;外部验证均方根误差(RMSEP)分别为0.115、1.31、0.583。结论: 本方法可用于银杏叶分散片生产过程在线或旁线分析,并作为GMP生产、质控的参考或替代方法,也可作为药品生产监管的重要手段之一。

Objective: To develop a near-infrared spectroscopy method and a chemometric method for rapid and nondestructive analysis of the content and the moisture of semi-manufactured product (finished product) generated from preparation granule drying of gingko leaf dispersible tablets. Methods: The near-infrared diffuse reflectance spectra (NIRDRS) of the intermediate product in the production process of gingko leaf dispersible tablets were collected, the quantitative models of moisture and total flavonol glycosides and terpene lactones content in the intermediate product were established by partial least squares (PLS) algorithm. Results: The results showed that the determination coefficient (R²) for moisture, total flavonol glycosides content and terpene lactones content were 0.9952, 0.9668 and 0.9528, respectively; the root mean square errors of cross validation (RMSECV) were 0.162, 2.97 and 1.43; the root mean square errors of prediction (RMSEP) were 0.115, 1.31 and 0.583. Conclusion: The established NIR methods can be used in drug production process online or sideline analysis and as the reference or alternative methods for GMP production and quality control, also can be used as one of the important means of pharmaceutical production supervision.