摘要
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 chemometrie 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 col- lected, the quantitative models of moisture and total flavonol glycosides and terpene lactones content in the interme- diate product were established by partial least squares （PLS） algorithm. Results：The results showed that the deter- mination 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 es- tablished NIR methods can be used in drug production process online or sideline analysis and as the reference or al- ternative methods for GMP production and quality control, also can be used as one of the important means of phar- maceutical production supervision.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2013年第1期63-68,共6页
Chinese Journal of Pharmaceutical Analysis
关键词
近红外漫反射光谱定量分析
银杏叶分散片
化学计量学
无损快速分析
水分含量
中药制剂
总黄酮醇苷
萜类内酯
在线或旁线分析
质量控制
near - infrared diffuse reflectance spectroscopy quantitative analysis
gingko leaf dispersible tablets
chemometrics
rapid and nondestructive analysis
moisture content
Chinese medicine preparations
total flavonolglycosides
terpene lactones
online or sideline analysis
quality control
