近红外光谱技术用于正天丸混合过程终点的判断  

End Point Judgment of Blending Process of Zhengtian Pills by Near Infrared Spectroscopy

作　　者：陈红英 李琼娅 陈佳乐[2] 栾连军[2] 代瑶霞 

机构地区：[1]华润三九医药股份有限公司,广东深圳518110 [2]浙江大学药学院,杭州310058

出　　处：《中国实验方剂学杂志》2016年第12期13-16,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家"重大新药创制"科技重大专项(2013ZX09201022)

摘　　要：目的:利用近红外光谱(near-infrared spectroscopy,NIR)技术分析正天丸的混合过程,建立一种快速判断混合终点的方法,以提高混合过程的均匀度和混合效率。方法:采用在线取样采集正天丸混合过程中粉末的NIR,计算不同时间点混合均匀度,利用主成分分析(principal component analysis,PCA)结合马氏距离判断粉末混合终点。采用HPLC测定不同混合时间点芍药苷含量以验证定性判断结果,检测波长235 nm,流动相0.05%磷酸-乙腈梯度洗脱。结果:随着混合时间的延长,粉末混合均匀度增大,20 min后达97%以上;PCA-马氏距离判断结果显示20 min后,到校正光谱的马氏距离基本保持不变(<1.0),提示混合达到均匀状态,定量验证结果显示20 min后芍药苷含量的RSD趋于稳定。结论:近红外光谱技术可用于判定正天丸的混合过程终点,为其他大品种制剂的研究提供了参考。Objective： A rapid method was established to judge the end point of blending process of Zhengtian pills by near-infrared spectroscopy, which was in order to improve blending efficiency of this preparation. Method： Near-infrared spectroscopy of blending samples were collected,then blending uniformity was calculated at different time. Principal component analysis（ PCA） combined with Mahalanobis distance was used to identify the end point of blending process. HPLC was employed to determine the content of paeoniflorin in order to verify judgment. Result： Blending uniformity of powders increased with blending time extended. After 20 min,blending uniformity reached more than 97%. PCA-Mahalanobis distance results showed that distance remained below1. 0 and kept unchanged basically,suggesting that blending process reached the end point. Quantitative validation results showed that RSD of paeoniflorin content tended to stable after 20 min. Conclusion： Near-infrared spectroscopy technology can be used to determine the end point of blending process of Zhengtian pills.

关 键 词：正天丸 近红外光谱 混合终点 马氏距离 主成分分析 

分 类 号：R283.6[医药卫生—中药学] R944.2[医药卫生—中医学]