近红外光谱法对银杏叶分散片混合均匀性的在线控制研究  

Online Control of the Mixing Uniformity of Ginkgo Leaf Dispersible Tablets Mixing Online Control by Near-Infrared Spectroscopy

作　　者：柳艳云 沈佳特 万文标 姜红 

机构地区：[1]湖北省食品药品监督检验研究院,武汉430064 [2]武汉武药科技有限公司,武汉430056

出　　处：《中国药学杂志》2014年第6期505-508,共4页Chinese Pharmaceutical Journal

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生产过程中的关键参数混合均匀性进行无损、快速分析,以控制产品质量。方法采集银杏叶分散片生产过程中初混、总混样品的近红外漫反射光谱(NIRDRS),分别用定量分析模型、光谱标准偏差法结合光谱马氏距离法分析初混、总混样品的光谱,监测混合均匀性,同时实验室自制混合样品,动态模拟混合过程进一步验证马氏距离法的可行性。结果定量分析模型和光谱标准偏差法所得混合均匀性结果一致,马氏距离法动态分析混合过程可行。结论本方法快速、简便,可用于银杏叶分散片生产过程中的混合过程在线或旁线分析。OBJECTIVE To establish a nondestructive and rapid analysis method to measure the critical parameter, mixing uni- formity, in the production of Ginkgo leaf dispersible tablets in order to control the quality of products. METHODS The near-infrared diffuse reflectance spectroscopy （NIRDRS） spectra of the pre-mix and the total mixed Ginkgo leaf dispersible tablets （Wuhan Jianmin Suizhou Pharmaceutical Co. , Ltd. ） were obtained. The mixing uniformity of samples was monitored by quantitative analysis model and standard deviation method combined with the Mahalanobis distance method, respectively. Meanwhile, lab-made mixing samples and dy- namic simulation mixing process were used to validate the feasibility of Mahalanobis distance method. RESULTS The results obtained from quantitative analysis model and standard deviation method were consistent with each other, and the Mahalanobis distance method was feasible for monitoring the mixing process. CONCLUSION The method is rapid, simple, and can be used for online and sideline anal- ysis in drug production process.

关 键 词：近红外漫反射光谱 过程分析 混合均匀性 银杏叶分散片 

分 类 号：R284[医药卫生—中药学]